Clinical efficacy and safety of immunotherapy after concurrent chemoradiotherapy in advanced esophageal cancer

Clinical efficacy and safety of immunotherapy after concurrent chemoradiotherapy in advanced esophageal cancer | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Clinical efficacy and safety of immunotherapy after concurrent chemoradiotherapy in advanced esophageal cancer CHUNXIU HU, YI LIU, ZHENGQI YANG, QIN CHEN, YUEFANG TONG, BIN DA, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7815083/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Purpose To investigate the efficacy and feasibility of PD-1 antibody combined with concurrent chemoradiotherapy on patients with esophageal cancer. Methods From July 2020 to October 2023,15 patients with esophageal cancer in Zhejiang Quhua Hospital were treated with PD-1 monoclonal antibody after concurrent chemoradiotherapy. Recording the incidence of adverse reactions, Kaplan Meier was used to evaluate the median survival and overall survival of patients. Results All 15 patients were enrolled, with a median follow-up of 23.0 months(ranging from 6.0ཞ37.5 months). 1-year and 2-year OS were 93.3% and 46.7%, respectively. No treatment-related deaths were reported. Conclusion A certain survival benefit of concurrent chemoradiotherapy combined with PD-1 antibody is affirmed for patients with esophageal cancer, which is worthy of further clinical exploration. esophageal cancer concurrent chemoradiotherapy Immune consolidation therapy clinical efficacy Figures Figure 1 Introduction As one of the most common cancer in the world, esophageal cancer(EC) shows a higher incidence and worse prognosis in elderly patients [ 1 ]. China is one of the regions with highly prevalence of esophageal cancer in the world, and its morbidity and mortality account for about 50% of the world [ 2 ]. Esophageal cancer in China is mainly esophageal squamous cell carcinoma(ESCC), accounting for more than 90%. The most general treatment is surgery and radiotherapy. Although the 5-year survival rate has increased to about 50% [ 3 ], more than half of patients will relapse after surgery. The early symptoms of esophageal cancer are atypical, and most patients are diagnosed in the middle and late stages, which leads to a poor prognosis [ 4 ]. Concurrent chemoradiotherapy is the standard care for unresectable, locally advanced esophageal cancer, but its clinical benefits are very limited [ 5 ]. Nowadays, the treatment of esophageal cancer includes surgery, radiotherapy and chemotherapy, but the treatment effect is not satisfying. These days, in addition to traditional regimens such as radiotherapy and chemotherapy, the use of immune checkpoint inhibitors(ICIs) has improved the prognosis of esophageal cancer patients. The immune system plays a crucial role in the development and progression of tumors, regulating the survival, growth, recognition, and elimination of tumor cells[ 6 ]. Inducing an effective anti-tumor immune response is a multi-step and complex process. Programmed cell death protein 1 (PD-1) drugs work by blocking the interaction between programmed death-ligand 1 ( PD-L1 ) on tumor cells and PD-1 on the surface of T cells, thus inhibiting their suppressive effect on T cells [ 7 ]. Compared to traditional treatment, immunotherapy has enhanced the efficacy of patients with esophageal cancer, prolonged survival, and caused minimal toxic side effects, bringing a new dawn for the treatment of esophageal cancer. However, the lack of phase III clinical trial data on the use of concurrent chemoradiotherapy combined with PD-1 monoclonal antibody consolidation therapy in esophageal cancer is a limitation. Therefore, this study aims to investigate the clinical efficacy and safety of concurrent chemoradiotherapy combined with PD-1 monoclonal antibody immunotherapy in esophageal cancer, as well as explore the correlation between the adverse reactions of immunotherapy and the prognosis of patients. Materials and Methods 1.1 Participants Information This retrospective analysis was conducted on 15 patients with advanced esophageal cancer admitted to Quzhou Hospital of Zhejiang Medical and Health Group ( Zhejiang Quhua Hospital ) from July 2020 to October 2023. Of these patients, there were 14 males and 1 female, aged 59 to 90 years old; 5 patients had a history of smoking and 4 patients had a habit of drinking history. 2 patients had cancer in the upper esophagus, and 13 patients had cancer in the middle and lower esophagus. Inclusion criteria : (1) Histologically confirmed esophageal squamous cell carcinoma ; (2) Stage III-IV ; (3) Received radical radiotherapy ± concurrent chemotherapy ; (4) No disease progression after radiotherapy, with indications for immune consolidation therapy. Exclusion criteria : (1) Severe comorbidities in internal medicine ; (2) History of other tumors ; (3) Eastern Cooperative Oncology Group(ECOG) score ≥ 3 points, or difficulty in tolerating treatment ; (4) Discontinuation of treatment due to serious adverse reactions. All patients signed informed consent, and the study has been approved by the ethics committee of Quzhou Hospital of Zhejiang Medical and Health Group. 1.2 Treament 1) Radiotherapy regimen: All patients received intensity-modulated radiation therapy (IMRT), with a radiation dose of 50.4Gy/28 fractions, 5 times per week, meanwhile the doses to organs at risk were within the reference limits. 2) Concurrent chemotherapy regimen: Adjust the dose according to the patient's body surface area, and administer 40-60mg of Tegio capsules orally twice daily for chemotherapy, from the first day of radiotherapy to the end of radiotherapy or from Monday to Friday of radiotherapy days. 3) Immunotherapy: 4–6 weeks after the end of radiotherapy, PD-1 monoclonal antibody was given to the immune therapy, including carrelizumab, palbolizumab, tereplizumab, and sindilizumab. If there is no indication of discontinuation, immunotherapy should be continued for 2 years. Discontinuation criteria include tumor progression, initiation of other treatments, or the onset of severe treatment-related adverse reactions. 1.3 Observe Indicators 1) Efficacy and safety: The therapeutic effect in patients is evaluated 3–4 weeks after the completion of radiotherapy and after 2 cycles of immunotherapy, using Response Evaluation Criteria in Solid Tumors(RECIST); and monitoring for the occurrence of adverse drug reactions during the treatment, through laboratory tests and physical examinations, with grading assessment according to the Radiation Therapy Oncology Group(RTOG) grading criteria. 2) Survival: Follow-up was conducted by phoning patients and gathering outpatient and inpatient medical records. The follow-up period started from the date of diagnosis, with a follow-up rate of 100%. Outcome measures included objective response rate, overall survival (OS), and progression-free survival (PFS). PFS was defined as the time from the start of treatment to disease progression; OS was defined as the time from the start of treatment to the date of follow-up cut-off (20th September 2024) or death. 1.4 Statistical Methods Using SPSS22.0 for statistical analysis of data, count data is expressed in frequencies or percentages (%), inter-group comparisons are conducted using χ2 test or Fisher's exact test; survival rate comparisons are calculated using the Kaplan-Meier method, and survival differences are compared using the log-rank test. P<0.05 indicates statistical significance. Results From July 2020 to October 2023, a total of 15 patients with esophageal cancer who received concurrent chemoradiotherapy combined with PD-1 monoclonal antibody immune consolidation therapy were enrolled. The clinical characteristics of the patients are shown in Table 1 . with a median age of 74 years old. The majority of the patients were male, and the tumor stages were mainly stage III-IV, with 11 patients in stage III and 4 patients in stage IV. Among the 15 patients, 12 received camrelizumab as consolidation therapy. Table 1 Characteristics of patients Characteristic Data(N=15) Age Median(range) 74 （ 59-90 ） Sex Male 14 Female 1 Smoking history Yes 5 No 10 Drinking history Yes 4 No 11 Hypertension Yes 7 No 8 Diabetes Yes 2 No 13 Location Upper thoracic segment 2 Middle/inferior thoracic segment 13 T stage T1-2 3 T3 10 T4 2 Disease stage IIIA-IIIB 11 IV 4 PD-1 drug pembrolizumab 1 camrelizumab 12 sintilimab 1 toripalimab 1 As of September 20, 2024, all 20 patients were included in the response analysis, no one achieved complete remission, 9 cases ( 60% ) had partial remission, 4 cases ( 26.7% ) remained stable, and 2 cases( 13.3% ) showed progression. The ORR was 60% and the DCR was 86.7%. Details are shown in Table 2 . Table2 Clinical response Response Number of Cases(%) CR 0 (0) PR 9 (60.0) SD 4 (26.7) PD 2 (13.3) ORR 9 (60.0) DCR 13 (86.7) Data are n (%).CR = complete response. PR = partial response. SD = stable disease.PD = progressive disease.ORR = objective response rate.DCR = disease control rate. The main immune-related adverse event(irAE) of the patients was hematological toxicity. 13 patients had varying degrees of bone marrow suppression in total, including 2 cases of grade III or above bone marrow suppression, all within a controllable range. Non-hematological toxic adverse reactions were mainly capillary hyperplasia and drug-induced liver function damage. There were no deaths during the treatment period. Table 3 Immune-related adverse events Immune-related adverse events All grade ≥ Grade 3 Anemia 12 2 Hypothyroidism 0 0 Dermatitis 1 0 Lung infection 1 0 hepatic dysfunction 2 0 autoimmune myocarditis 0 0 Reactive capillary hemangioma 3 0 Using the Kaplan-Meier method to evaluate the survival status of patients, the follow-up time of 15 patients ranged from 6 to 37.5 months, with a median follow-up time of 23 months. The median PFS was between 6 and 93 months, with a median PFS of 19 months (95%CI 6–93); the median OS reached 23 months (95%CI 11–100). 1-year and 2-year OS rates were 93.3% and 46.7%, and 1-year and 2-year PFS rates were 73.3% and 40.0%, respectively(Fig. 1 ). Discussion The incidence of malignant tumors in China is increasing year by year, especially thoracic malignant tumors represented by lung cancer and esophageal cancer. Esophageal cancer is one of the most common malignant tumors in the world, especially in the elderly. With a higher incidence rate and poor prognosis [ 8 ]. For locally advanced esophageal cancer, radical chemoradiotherapy is the standard treatment, and its efficacy is equivalent to surgery [ 9 ]. However, local recurrence still occurs in 50% of patients after chemoradiotherapy. With the rapid development of immunotherapy, the treatment of ICIs in tumors has been affirmed [ 10 ]. KEYNOTE-028, as a multicenter phase I study, is the first attempt at ICIs in esophageal cancer. The study found that single-agent pembrolizumab treatment for esophageal cancer had an overall response rate of 30% and good safety. This study demonstrated that pembrolizumab has a certain anti-tumor effect on PD-L1 positive esophageal cancer patients. The subsequent publication of clinical trial results such as KEYNOTE-181, ATTRACTION-3, and ESCORT led to the inclusion of pembrolizumab and nivolumab as expert first-level recommended treatment options in the 2020 CSCO Esophageal Cancer Diagnosis and Treatment Guidelines, establishing the important position of immunotherapy in the second-line treatment of advanced esophageal squamous cell carcinoma[ 11 ]. These studies have confirmed the good clinical efficacy of immunotherapy in the treatment of advanced esophageal cancer, which has now become a standard first-line and second-line treatment option, prolonging patient survival with minimal toxic side effects. Animal models have confirmed the synergistic effects of radiotherapy and ICIs[ 12 – 13 ]. Exploring the clinical benefits of chemoradiotherapy combined with immunotherapy in cancer patients has also achieved certain results. The PACIFIC study [ 14 ] is an important achievement of clinical radiotherapy combined with immunotherapy. For unresectable stage III NSCLC patients, after receiving concurrent chemoradiotherapy, the use of PD-L1 monoclonal antibody to maintain the treatment of the patient's PFS period was extended by 11.3 months ( 16.9 months in the dulaglizumab group vs 5.6 months in the placebo group ), and the 5-year OS rate was 42.9%. The study results also showed that the symptoms, functions or health-related quality of life of patients treated with durvalizumab did not deteriorate. This research outcome has been incorporated into the National Comprehensive Cancer Network ( NCCN ) clinical practice and has become one of the treatment options for NSCLC after radical radiotherapy and chemotherapy. The ADRIATIC study presented at the 2024 American Society of Clinical Oncology (ASCO) conference [ 15 ] studies immune consolidation therapy in limited-stage SCLC. The interim analysis results showed that the mPFS of patients reached 16.6 months and the mOS was 55.9 months after concurrent chemoradiotherapy, bringing dual benefits of PFS and OS to limited-stage SCLC and establishing a new treatment model of immunotherapy consolidation after radiochemotherapy for limited-stage SCLC. Although the comprehensive treatment of radiotherapy and chemotherapy combined with immunotherapy has become the recommended treatment for some malignant tumors, there is still a lack of phase III clinical research reports on radiochemotherapy combined with immunotherapy for esophageal cancer. Similarly, the efficacy of immunotherapy in esophageal cancer is also worth anticipating. A late systematic review and meta-analysis indicated that the mortality rate caused by the toxic effects of immune checkpoint inhibitors ranged from 0.3% to 1.3% [ 16 ]. Among the patients in this study, the median follow-up time was 23 months ( 95% CI 6–93 ), the 1-year OS rate was 93.3%, the 1-year PFS rate was 73.3%. Two patients experienced Grade 3 or higher toxic reactions. In a study [ 17 ] by Professor Wang Jun, the interim report showed a median follow-up time of 15 months, with no occurrence of Grade 3–4 toxic reactions, demonstrating good efficacy, but the OS and PFS have not been reached yet. Professor Zhang Wencheng 's study in 2021 [ 18 ] explored the efficacy and safety of carrelizumab combined with concurrent chemoradiotherapy as a first-line treatment for esophageal cancer. The results showed that the median follow-up of 20 patients was 23.7 months ( 95%CI 21.9–24.5 ), with 12-month OS and PFS rates of 85.0% and 65.0%, respectively. Eight patients experienced severe adverse reactions. The results of this study and our research suggest that patients with esophageal cancer may benefit from receiving immunotherapy consolidation therapy after synchronous radiochemotherapy, with good tolerance to toxic reactions. However, due to the small number of patients and the heterogeneity of patient baseline data, bias in results may occur, and further clinical research is warranted. The results of this study show that the combination of concurrent chemoradiotherapy and PD-1 monoclonal antibody immunotherapy has a certain therapeutic effect on esophageal cancer patients, which can prolong the survival time of patients to a certain extent and has clinical feasibility. Commonly used chemotherapy drugs include paclitaxel, platinum agents (cisplatin/oxaliplatin/carboplatin), fluoropyrimidines (5-fluorouracil/capecitabine), etc. Patients with general conditions permit priority to consider the two-drug combination regimen. It is recommended to administer 35 cycles of PD-1 monoclonal antibody immune consolidation therapy. Due to the limited number of cases contained in this study, the status of concurrent chemoradiotherapy combined with PD-1 monoclonal antibody immune consolidation therapy in esophageal cancer needs further large sample study. In addition, in the comprehensive treatment of radiotherapy combined with immunization, the selection of immunotherapy drugs, the dosage and target area of radiotherapy, and likewise the volume needs to be considered. Declarations Fund programs Science and Technology Innovation Guidance Fund of Hangzhou Medical College(CX2022019); Special Fund Project of Zhejiang Provincial Medical Association Clinical Medicine(2024ZYC-B100) Author Contribution HU and LIU wrote the main manuscript text and YANG,CHEN,TONG prepared clinical data and DA,SUN prepared figures 1-2,RAO edited the artic and did final checking. All authors reviewed the manuscript References Lagergren J, Bottai M, Santoni G. Patient Age and Survival After Surgery for Esophageal Cancer[J]. Ann Surg Oncol 2021,28(1): 159–66. Qiao YL. An important milestone in the epidemiological study of esophageal cancer [J]. Chin J Clin Oncol 2016,43(12): 500–1. Mao YS, Gao SG, Wang Q et al. Epidemiological characteristics and current status of surgical treatment for esophageal cancer by analysis of national registry database [J]. Chin J Oncol 2020,42(3): 228–33. Chen J, Wu F, Pei HL, et al. Analysis of the correlation between P53 and Cox-2 expression and prognosis in esophageal cancer [. J] Oncol Lett. 2015;10(4):2197–203. Cooper JS, Guo MD, Herskovic A, et al. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85 – 01). Radiation Therapy Oncol Group[J] JAMA. 1999;281–17–:1623–7. Jiang X, Wang J, Deng X et al. Role of the tumor microenvironment in PD-L1/PD-1 mediated tumor immune escape[J].Molcancer,2019,18(1):10. Mcdermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med. 2013;2(5):662–73. Lagergren J, Bottai M, Santoni G. Patient Age and Survival After Surgery for Esophageal Cancer[J]. Ann Surg Oncol. 2021;28(1):159–66. Stahl M, Stuschke M, Lehmann N, et al. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus[J]. J Clin Oncol. 2005;23(10):2310–7. Mirzaei HR, Rodriguez A, Shepphird J, et al. Chimeric antigen receptors T cell therapy in solid tumor challenges and clinical applications [J]. Front Immunol. 2017;8:1850. Jiao X, Lu ZH. An annual review of advances in esophageal cancer in 2020 [J]. J Multidisciplinary Cancer Manage (Electronic Version), 2021, (1):11–6. Park SS, Dong H, Liu X et al. PD-1 restrains radiotherapy-induced abscopal effect [J]. Cancer Immunol Res, 2015, 3(6). Deng L, Liang H, Burnette B et al. Irradiation and anti-PD-L1 treatment synergistically promote antitumor immunity in mice[J]. J Clin Invest 2014, 124(2):687–95. Antonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non-small cell lung cancer[J]. N Engl J Med. 2017;377(20):1919–29. Spigel DR, Cheng Y, ,Cho BC. ,et al.ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC).[J]. J Clin Oncol. 2024;42(17suppl):LBA5–5. Wang DY, Salem J-E, Cohen JV et al. Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis.JAMA Oncology.2018. Wang J et al. 1262TiP Efficacy and safety of consolidative camrelizumab following definitive concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell cancer.Annals of Oncology (2022): n. pag. Zhang W, Yan C, Zhang T, et al. Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study. Oncoimmunology. 2021;10(1):1971418. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 25 Jan, 2026 Reviews received at journal 25 Jan, 2026 Reviewers agreed at journal 16 Jan, 2026 Reviewers invited by journal 06 Jan, 2026 Editor assigned by journal 14 Oct, 2025 Submission checks completed at journal 14 Oct, 2025 First submitted to journal 09 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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China is one of the regions with highly prevalence of esophageal cancer in the world, and its morbidity and mortality account for about 50% of the world [\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e]. Esophageal cancer in China is mainly esophageal squamous cell carcinoma(ESCC), accounting for more than 90%. The most general treatment is surgery and radiotherapy. Although the 5-year survival rate has increased to about 50% [\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e], more than half of patients will relapse after surgery. The early symptoms of esophageal cancer are atypical, and most patients are diagnosed in the middle and late stages, which leads to a poor prognosis [\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e]. Concurrent chemoradiotherapy is the standard care for unresectable, locally advanced esophageal cancer, but its clinical benefits are very limited [\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e]. Nowadays, the treatment of esophageal cancer includes surgery, radiotherapy and chemotherapy, but the treatment effect is not satisfying. These days, in addition to traditional regimens such as radiotherapy and chemotherapy, the use of immune checkpoint inhibitors(ICIs) has improved the prognosis of esophageal cancer patients. The immune system plays a crucial role in the development and progression of tumors, regulating the survival, growth, recognition, and elimination of tumor cells[\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e]. Inducing an effective anti-tumor immune response is a multi-step and complex process. Programmed cell death protein 1 (PD-1) drugs work by blocking the interaction between programmed death-ligand 1 ( PD-L1 ) on tumor cells and PD-1 on the surface of T cells, thus inhibiting their suppressive effect on T cells [\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e]. Compared to traditional treatment, immunotherapy has enhanced the efficacy of patients with esophageal cancer, prolonged survival, and caused minimal toxic side effects, bringing a new dawn for the treatment of esophageal cancer. However, the lack of phase III clinical trial data on the use of concurrent chemoradiotherapy combined with PD-1 monoclonal antibody consolidation therapy in esophageal cancer is a limitation. Therefore, this study aims to investigate the clinical efficacy and safety of concurrent chemoradiotherapy combined with PD-1 monoclonal antibody immunotherapy in esophageal cancer, as well as explore the correlation between the adverse reactions of immunotherapy and the prognosis of patients.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003e1.1 Participants Information\u003c/h2\u003e \u003cp\u003eThis retrospective analysis was conducted on 15 patients with advanced esophageal cancer admitted to Quzhou Hospital of Zhejiang Medical and Health Group ( Zhejiang Quhua Hospital ) from July 2020 to October 2023. Of these patients, there were 14 males and 1 female, aged 59 to 90 years old; 5 patients had a history of smoking and 4 patients had a habit of drinking history. 2 patients had cancer in the upper esophagus, and 13 patients had cancer in the middle and lower esophagus. Inclusion criteria : (1) Histologically confirmed esophageal squamous cell carcinoma ; (2) Stage III-IV ; (3) Received radical radiotherapy\u0026thinsp;\u0026plusmn;\u0026thinsp;concurrent chemotherapy ; (4) No disease progression after radiotherapy, with indications for immune consolidation therapy. Exclusion criteria : (1) Severe comorbidities in internal medicine ; (2) History of other tumors ; (3) Eastern Cooperative Oncology Group(ECOG) score\u0026thinsp;\u0026ge;\u0026thinsp;3 points, or difficulty in tolerating treatment ; (4) Discontinuation of treatment due to serious adverse reactions. All patients signed informed consent, and the study has been approved by the ethics committee of Quzhou Hospital of Zhejiang Medical and Health Group.\u003c/p\u003e \u003cp\u003e1.2 Treament\u003c/p\u003e \u003cp\u003e1) Radiotherapy regimen: All patients received intensity-modulated radiation therapy (IMRT), with a radiation dose of 50.4Gy/28 fractions, 5 times per week, meanwhile the doses to organs at risk were within the reference limits.\u003c/p\u003e \u003cp\u003e2) Concurrent chemotherapy regimen: Adjust the dose according to the patient's body surface area, and administer 40-60mg of Tegio capsules orally twice daily for chemotherapy, from the first day of radiotherapy to the end of radiotherapy or from Monday to Friday of radiotherapy days.\u003c/p\u003e \u003cp\u003e3) Immunotherapy: 4\u0026ndash;6 weeks after the end of radiotherapy, PD-1 monoclonal antibody was given to the immune therapy, including carrelizumab, palbolizumab, tereplizumab, and sindilizumab. If there is no indication of discontinuation, immunotherapy should be continued for 2 years. Discontinuation criteria include tumor progression, initiation of other treatments, or the onset of severe treatment-related adverse reactions.\u003c/p\u003e \u003cp\u003e1.3 Observe Indicators\u003c/p\u003e \u003cp\u003e1) Efficacy and safety: The therapeutic effect in patients is evaluated 3\u0026ndash;4 weeks after the completion of radiotherapy and after 2 cycles of immunotherapy, using Response Evaluation Criteria in Solid Tumors(RECIST); and monitoring for the occurrence of adverse drug reactions during the treatment, through laboratory tests and physical examinations, with grading assessment according to the Radiation Therapy Oncology Group(RTOG) grading criteria.\u003c/p\u003e \u003cp\u003e2) Survival: Follow-up was conducted by phoning patients and gathering outpatient and inpatient medical records. The follow-up period started from the date of diagnosis, with a follow-up rate of 100%. Outcome measures included objective response rate, overall survival (OS), and progression-free survival (PFS). PFS was defined as the time from the start of treatment to disease progression; OS was defined as the time from the start of treatment to the date of follow-up cut-off (20th September 2024) or death.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003e1.4 Statistical Methods\u003c/h2\u003e \u003cp\u003eUsing SPSS22.0 for statistical analysis of data, count data is expressed in frequencies or percentages (%), inter-group comparisons are conducted using χ2 test or Fisher's exact test; survival rate comparisons are calculated using the Kaplan-Meier method, and survival differences are compared using the log-rank test. P\u0026lt;0.05 indicates statistical significance.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eFrom July 2020 to October 2023, a total of 15 patients with esophageal cancer who received concurrent chemoradiotherapy combined with PD-1 monoclonal antibody immune consolidation therapy were enrolled. The clinical characteristics of the patients are shown in Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e. with a median age of 74 years old. The majority of the patients were male, and the tumor stages were mainly stage III-IV, with 11 patients in stage III and 4 patients in stage IV. Among the 15 patients, 12 received camrelizumab as consolidation therapy.\u003c/p\u003e\n\u003cp\u003eTable 1 Characteristics of patients\u003c/p\u003e\n\u003ctable style=\"float: collapse;border: none;margin-left: 6.75pt;margin-right: 6.75pt;width: 557px;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 417.85pt;border-top: 1pt solid windowtext;border-left: none;border-bottom: 1pt solid windowtext;border-right: none;padding: 0in 5.4pt;height: 18.6pt;vertical-align: top;\"\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;Characteristic \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Data(N=15)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 417.85pt;border-top: none;border-right: none;border-left: none;border-image: initial;border-bottom: 1pt solid windowtext;padding: 0in 5.4pt;height: 25.25pt;vertical-align: top;\"\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eAge\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eMedian(range) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 74\u003c/span\u003e\u003cspan style=\"font-size:20px;line-height:150%;font-family:SimSun;color:black;\"\u003e（\u003c/span\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e59-90\u003c/span\u003e\u003cspan style=\"font-size:20px;line-height:150%;font-family:SimSun;color:black;\"\u003e）\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eSex\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:24.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height: 150%;font-family:\"Times New Roman\",serif;color:black;'\u003eMale \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;14\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:24.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height: 150%;font-family:\"Times New Roman\",serif;color:black;'\u003eFemale \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 1\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eSmoking history\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:24.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height: 150%;font-family:\"Times New Roman\",serif;color:black;'\u003eYes \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;5\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:24.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height: 150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNo \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;10\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eDrinking history\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eYes \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 4\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNo \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 11\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eHypertension\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eYes \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 7\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNo \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 8\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eDiabetes\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eYes \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 2\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eNo \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 13\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eLocation\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eUpper thoracic segment \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 2\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp; Middle/inferior thoracic segment \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 13\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eT stage\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eT1-2 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;3\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eT3 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 10\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:30.0pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eT4 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;2\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eDisease stage\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp; IIIA-IIIB \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;11\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:justify;font-size:16px;font-family:DengXian;text-indent:30.0pt;\"\u003e\u003cspan style='font-size:20px;font-family:\"Times New Roman\",serif;color:black;'\u003eIV \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;4\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003ePD-1 drug\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp;pembrolizumab \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;1\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp;camrelizumab \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 12\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp; \u0026nbsp;sintilimab \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;1\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;text-indent:22.5pt;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003etoripalimab \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 1\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003e\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n\u003cp\u003eAs of September 20, 2024, all 20 patients were included in the response analysis, no one achieved complete remission, 9 cases ( 60% ) had partial remission, 4 cases ( 26.7% ) remained stable, and 2 cases( 13.3% ) showed progression. The ORR was 60% and the DCR was 86.7%. Details are shown in Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003eTable2 Clinical response\u003c/p\u003e\n\u003ctable style=\"float: border-collapse: collapse;border: none;margin-left: 6.75pt;margin-right: 6.75pt;width: 554px;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 415.3pt;border-top: 1pt solid windowtext;border-left: none;border-bottom: 1pt solid windowtext;border-right: none;padding: 0in 5.4pt;height: 18.6pt;vertical-align: top;\"\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eResponse \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Number of Cases(%) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 415.3pt;border-top: none;border-right: none;border-left: none;border-image: initial;border-bottom: 1pt solid windowtext;padding: 0in 5.4pt;height: 25.25pt;vertical-align: top;\"\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eCR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0 \u0026nbsp;(0)\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003ePR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;9 \u0026nbsp;(60.0)\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eSD \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;4 \u0026nbsp;(26.7)\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003ePD \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;2 \u0026nbsp;(13.3)\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eORR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 9 \u0026nbsp;(60.0)\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eDCR \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 13 (86.7)\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eData are n (%).CR\u0026thinsp;=\u0026thinsp;complete response. PR\u0026thinsp;=\u0026thinsp;partial response. SD\u0026thinsp;=\u0026thinsp;stable disease.PD\u0026thinsp;=\u0026thinsp;progressive disease.ORR\u0026thinsp;=\u0026thinsp;objective response rate.DCR\u0026thinsp;=\u0026thinsp;disease control rate.\u003c/p\u003e\n\u003cp\u003eThe main immune-related adverse event(irAE) of the patients was hematological toxicity. 13 patients had varying degrees of bone marrow suppression in total, including 2 cases of grade III or above bone marrow suppression, all within a controllable range. Non-hematological toxic adverse reactions were mainly capillary hyperplasia and drug-induced liver function damage. There were no deaths during the treatment period.\u003c/p\u003e\n\u003cp\u003eTable 3 Immune-related adverse events\u003c/p\u003e\n\u003ctable style=\"float: border-collapse: collapse;border: none;margin-left: 6.75pt;margin-right: 6.75pt;width: 557px;\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 417.85pt;border-top: 1pt solid windowtext;border-left: none;border-bottom: 1pt solid windowtext;border-right: none;padding: 0in 5.4pt;height: 18.6pt;vertical-align: top;\"\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eImmune-related adverse events \u0026nbsp; \u0026nbsp; All grade \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026ge; Grade 3\u0026nbsp;\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 417.85pt;border-top: none;border-right: none;border-left: none;border-image: initial;border-bottom: 1pt solid windowtext;padding: 0in 5.4pt;height: 25.25pt;vertical-align: top;\"\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eAnemia \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;12 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 2\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eHypothyroidism \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eDermatitis \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;1 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eLung infection \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 1 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003ehepatic dysfunction \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 2 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:left;font-size:16px;font-family:DengXian;line-height:150%;\"\u003e\u003cspan style='font-size:20px;line-height:150%;font-family:\"Times New Roman\",serif;color:black;'\u003eautoimmune myocarditis \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; 0 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0\u003c/span\u003e\u003c/p\u003e\n \u003cp style=\"margin:0in;text-align:justify;font-size:16px;font-family:DengXian;\"\u003e\u003cspan style='font-size:20px;font-family:\"Times New Roman\",serif;color:black;'\u003eReactive capillary hemangioma \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;3 \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;0\u003c/span\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cdiv class=\"gridtable\"\u003eUsing the Kaplan-Meier method to evaluate the survival status of patients, the follow-up time of 15 patients ranged from 6 to 37.5 months, with a median follow-up time of 23 months. The median PFS was between 6 and 93 months, with a median PFS of 19 months (95%CI 6\u0026ndash;93); the median OS reached 23 months (95%CI 11\u0026ndash;100). 1-year and 2-year OS rates were 93.3% and 46.7%, and 1-year and 2-year PFS rates were 73.3% and 40.0%, respectively(Fig. \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/div\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe incidence of malignant tumors in China is increasing year by year, especially thoracic malignant tumors represented by lung cancer and esophageal cancer. Esophageal cancer is one of the most common malignant tumors in the world, especially in the elderly. With a higher incidence rate and poor prognosis [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. For locally advanced esophageal cancer, radical chemoradiotherapy is the standard treatment, and its efficacy is equivalent to surgery [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, local recurrence still occurs in 50% of patients after chemoradiotherapy. With the rapid development of immunotherapy, the treatment of ICIs in tumors has been affirmed [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. KEYNOTE-028, as a multicenter phase I study, is the first attempt at ICIs in esophageal cancer. The study found that single-agent pembrolizumab treatment for esophageal cancer had an overall response rate of 30% and good safety. This study demonstrated that pembrolizumab has a certain anti-tumor effect on PD-L1 positive esophageal cancer patients. The subsequent publication of clinical trial results such as KEYNOTE-181, ATTRACTION-3, and ESCORT led to the inclusion of pembrolizumab and nivolumab as expert first-level recommended treatment options in the 2020 CSCO Esophageal Cancer Diagnosis and Treatment Guidelines, establishing the important position of immunotherapy in the second-line treatment of advanced esophageal squamous cell carcinoma[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. These studies have confirmed the good clinical efficacy of immunotherapy in the treatment of advanced esophageal cancer, which has now become a standard first-line and second-line treatment option, prolonging patient survival with minimal toxic side effects.\u003c/p\u003e \u003cp\u003eAnimal models have confirmed the synergistic effects of radiotherapy and ICIs[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. Exploring the clinical benefits of chemoradiotherapy combined with immunotherapy in cancer patients has also achieved certain results. The PACIFIC study [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] is an important achievement of clinical radiotherapy combined with immunotherapy. For unresectable stage III NSCLC patients, after receiving concurrent chemoradiotherapy, the use of PD-L1 monoclonal antibody to maintain the treatment of the patient's PFS period was extended by 11.3 months ( 16.9 months in the dulaglizumab group vs 5.6 months in the placebo group ), and the 5-year OS rate was 42.9%. The study results also showed that the symptoms, functions or health-related quality of life of patients treated with durvalizumab did not deteriorate. This research outcome has been incorporated into the National Comprehensive Cancer Network ( NCCN ) clinical practice and has become one of the treatment options for NSCLC after radical radiotherapy and chemotherapy. The ADRIATIC study presented at the 2024 American Society of Clinical Oncology (ASCO) conference [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] studies immune consolidation therapy in limited-stage SCLC. The interim analysis results showed that the mPFS of patients reached 16.6 months and the mOS was 55.9 months after concurrent chemoradiotherapy, bringing dual benefits of PFS and OS to limited-stage SCLC and establishing a new treatment model of immunotherapy consolidation after radiochemotherapy for limited-stage SCLC. Although the comprehensive treatment of radiotherapy and chemotherapy combined with immunotherapy has become the recommended treatment for some malignant tumors, there is still a lack of phase III clinical research reports on radiochemotherapy combined with immunotherapy for esophageal cancer. Similarly, the efficacy of immunotherapy in esophageal cancer is also worth anticipating. A late systematic review and meta-analysis indicated that the mortality rate caused by the toxic effects of immune checkpoint inhibitors ranged from 0.3% to 1.3% [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Among the patients in this study, the median follow-up time was 23 months ( 95% CI 6\u0026ndash;93 ), the 1-year OS rate was 93.3%, the 1-year PFS rate was 73.3%. Two patients experienced Grade 3 or higher toxic reactions. In a study [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] by Professor Wang Jun, the interim report showed a median follow-up time of 15 months, with no occurrence of Grade 3\u0026ndash;4 toxic reactions, demonstrating good efficacy, but the OS and PFS have not been reached yet. Professor Zhang Wencheng 's study in 2021 [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] explored the efficacy and safety of carrelizumab combined with concurrent chemoradiotherapy as a first-line treatment for esophageal cancer. The results showed that the median follow-up of 20 patients was 23.7 months ( 95%CI 21.9\u0026ndash;24.5 ), with 12-month OS and PFS rates of 85.0% and 65.0%, respectively. Eight patients experienced severe adverse reactions. The results of this study and our research suggest that patients with esophageal cancer may benefit from receiving immunotherapy consolidation therapy after synchronous radiochemotherapy, with good tolerance to toxic reactions. However, due to the small number of patients and the heterogeneity of patient baseline data, bias in results may occur, and further clinical research is warranted.\u003c/p\u003e \u003cp\u003eThe results of this study show that the combination of concurrent chemoradiotherapy and PD-1 monoclonal antibody immunotherapy has a certain therapeutic effect on esophageal cancer patients, which can prolong the survival time of patients to a certain extent and has clinical feasibility. Commonly used chemotherapy drugs include paclitaxel, platinum agents (cisplatin/oxaliplatin/carboplatin), fluoropyrimidines (5-fluorouracil/capecitabine), etc. Patients with general conditions permit priority to consider the two-drug combination regimen. It is recommended to administer 35 cycles of PD-1 monoclonal antibody immune consolidation therapy. Due to the limited number of cases contained in this study, the status of concurrent chemoradiotherapy combined with PD-1 monoclonal antibody immune consolidation therapy in esophageal cancer needs further large sample study. In addition, in the comprehensive treatment of radiotherapy combined with immunization, the selection of immunotherapy drugs, the dosage and target area of radiotherapy, and likewise the volume needs to be considered.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e \u003ch2\u003eFund programs\u003c/h2\u003e \u003cp\u003eScience and Technology Innovation Guidance Fund of Hangzhou Medical College(CX2022019); Special Fund Project of Zhejiang Provincial Medical Association Clinical Medicine(2024ZYC-B100)\u003c/p\u003e \u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eHU and LIU wrote the main manuscript text and YANG,CHEN,TONG prepared clinical data and DA,SUN prepared figures 1-2,RAO edited the artic and did final checking. All authors reviewed the manuscript\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eLagergren J, Bottai M, Santoni G. Patient Age and Survival After Surgery for Esophageal Cancer[J]. Ann Surg Oncol 2021,28(1): 159\u0026ndash;66.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQiao YL. An important milestone in the epidemiological study of esophageal cancer [J]. Chin J Clin Oncol 2016,43(12): 500\u0026ndash;1.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMao YS, Gao SG, Wang Q et al. Epidemiological characteristics and current status of surgical treatment for esophageal cancer by analysis of national registry database [J]. Chin J Oncol 2020,42(3): 228\u0026ndash;33.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChen J, Wu F, Pei HL, et al. Analysis of the correlation between P53 and Cox-2 expression and prognosis in esophageal cancer [. J] Oncol Lett. 2015;10(4):2197\u0026ndash;203.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCooper JS, Guo MD, Herskovic A, et al. Chemoradiotherapy of locally advanced esophageal cancer: long-term follow-up of a prospective randomized trial (RTOG 85\u0026thinsp;\u0026ndash;\u0026thinsp;01). Radiation Therapy Oncol Group[J] JAMA. 1999;281\u0026ndash;17\u0026ndash;:1623\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJiang X, Wang J, Deng X et al. Role of the tumor microenvironment in PD-L1/PD-1 mediated tumor immune escape[J].Molcancer,2019,18(1):10.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMcdermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med. 2013;2(5):662\u0026ndash;73.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLagergren J, Bottai M, Santoni G. Patient Age and Survival After Surgery for Esophageal Cancer[J]. Ann Surg Oncol. 2021;28(1):159\u0026ndash;66.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eStahl M, Stuschke M, Lehmann N, et al. Chemoradiation with and without surgery in patients with locally advanced squamous cell carcinoma of the esophagus[J]. J Clin Oncol. 2005;23(10):2310\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMirzaei HR, Rodriguez A, Shepphird J, et al. Chimeric antigen receptors T cell therapy in solid tumor challenges and clinical applications [J]. Front Immunol. 2017;8:1850.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJiao X, Lu ZH. An annual review of advances in esophageal cancer in 2020 [J]. J Multidisciplinary Cancer Manage (Electronic Version), 2021, (1):11\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePark SS, Dong H, Liu X et al. PD-1 restrains radiotherapy-induced abscopal effect [J]. Cancer Immunol Res, 2015, 3(6).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDeng L, Liang H, Burnette B et al. Irradiation and anti-PD-L1 treatment synergistically promote antitumor immunity in mice[J]. J Clin Invest 2014, 124(2):687\u0026ndash;95.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAntonia SJ, Villegas A, Daniel D, et al. Durvalumab after chemoradiotherapy in stage III non-small cell lung cancer[J]. N Engl J Med. 2017;377(20):1919\u0026ndash;29.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSpigel DR, Cheng Y, ,Cho BC. ,et al.ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC).[J]. J Clin Oncol. 2024;42(17suppl):LBA5\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang DY, Salem J-E, Cohen JV et al. Fatal Toxic Effects Associated With Immune Checkpoint Inhibitors: A Systematic Review and Meta-analysis.JAMA Oncology.2018.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWang J et al. 1262TiP Efficacy and safety of consolidative camrelizumab following definitive concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell cancer.Annals of Oncology (2022): n. pag.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang W, Yan C, Zhang T, et al. Addition of camrelizumab to docetaxel, cisplatin, and radiation therapy in patients with locally advanced esophageal squamous cell carcinoma: a phase 1b study. Oncoimmunology. 2021;10(1):1971418.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"journal-of-cardiothoracic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jcts","sideBox":"Learn more about [Journal of Cardiothoracic Surgery](http://cardiothoracicsurgery.biomedcentral.com)","snPcode":"13019","submissionUrl":"https://submission.nature.com/new-submission/13019/3","title":"Journal of Cardiothoracic Surgery","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"esophageal cancer, concurrent chemoradiotherapy, Immune consolidation therapy, clinical efficacy","lastPublishedDoi":"10.21203/rs.3.rs-7815083/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7815083/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003ePurpose\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo investigate the efficacy and feasibility of PD-1 antibody combined with concurrent chemoradiotherapy on patients with esophageal cancer.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFrom July 2020 to October 2023,15 patients with esophageal cancer in Zhejiang Quhua Hospital were treated with PD-1 monoclonal antibody after concurrent chemoradiotherapy. Recording the incidence of adverse reactions, Kaplan Meier was used to evaluate the median survival and overall survival of patients.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll 15 patients were enrolled, with a median follow-up of 23.0 months(ranging from 6.0ཞ37.5 months). 1-year and 2-year OS were 93.3% and 46.7%, respectively. No treatment-related deaths were reported.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA certain survival benefit of concurrent chemoradiotherapy combined with PD-1 antibody is affirmed for patients with esophageal cancer, which is worthy of further clinical exploration.\u003c/p\u003e","manuscriptTitle":"Clinical efficacy and safety of immunotherapy after concurrent chemoradiotherapy in advanced esophageal cancer","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-12 05:33:35","doi":"10.21203/rs.3.rs-7815083/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-01-25T17:50:07+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-01-25T12:45:19+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"220263755342623778406277730739280182673","date":"2026-01-16T14:10:18+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-01-06T16:58:17+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-15T03:06:32+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-10-15T03:05:47+00:00","index":"","fulltext":""},{"type":"submitted","content":"Journal of Cardiothoracic Surgery","date":"2025-10-09T08:34:03+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"journal-of-cardiothoracic-surgery","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"jcts","sideBox":"Learn more about [Journal of Cardiothoracic Surgery](http://cardiothoracicsurgery.biomedcentral.com)","snPcode":"13019","submissionUrl":"https://submission.nature.com/new-submission/13019/3","title":"Journal of Cardiothoracic Surgery","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b569a3de-6b06-4b00-badd-09e27d5895d3","owner":[],"postedDate":"January 12th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-04-23T18:23:06+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-12 05:33:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7815083","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7815083","identity":"rs-7815083","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}