Preoperative administration of camrelizumab combined with chemotherapy for borderline resectable esophageal squamous cell carcinoma (BRES-1): A single-arm, open-label, phase II study

Abstract Background The prognosis and first-line treatment response of patients with borderline resectable esophageal squamous cell carcinoma are unsatisfactory. We are conducting the BRES-1 study to evaluate the safety and efficacy of camrelizumab combined with chemotherapy in patients with borderline resectable esophageal squamous cell carcinoma.Methods A total of 30 patients with borderline resectable esophageal squamous cell carcinoma will be enrolled in the BRES-1 study. These patients will undergo three stages of treatment: neoadjuvant therapy, surgery, and adjuvant therapy. Preoperative therapies will include camrelizumab, cisplatin and nab-paclitaxel. Patients will undergo esophagectomy 3–4 weeks after completing the neoadjuvant treatment. Three weeks after surgery, camrelizumab combined with chemotherapy will continue to be used for two cycles of maintenance therapy. Then, only camrelizumab will be administered for an entire year. The primary endpoint of this study will be pathological complete response (pCR).Discussion The BRES-1 trial will evaluate the efficacy and safety of camrelizumab combined with chemotherapy for patients with borderline resectable esophageal squamous cell carcinoma. Translational research will explore perioperative complications and drug-related adverse events.Trial registration ChiCTR, ChiCTR2200056728. Registered 11 February 2022. https://www.chictr.org.cn/index.aspx