Effects of Traditional Chinese Medicine Combined With Chemotherapy for Extensive-stage Small-cell Lung Cancer Patients on Improving Oncologic Survival: Study Protocol of a Multicenter, Randomized, Single-blind, Placebo-controlled Trial

Background: Extensive-stage small-cell lung cancer (ES-SCLC) is characterized by extensive metastases, aggressive progression and poor prognosis. Chemotherapy is applied as a preferred first-line regimen for ES-SCLC, but inadequate for improvingits overall survival. Traditional Chinese medicine (TCM) is widely used in the clinical practice of ES-SCLC for its synergy with chemotherapy. However, there is still no substantial evidence to prove that TCM can effectively improve the long-term efficacy of ES-SCLC patients. The study intends to determine whether theTCM with chemotherapy can improve the overall survival (OS) in treating with ES-SCLC when compared with chemotherapy alone. Method: /design: A multicenter, randomized, single-blind, placebo-controlled clinical trial will be conducted to determine whether the TCM granules combined with chemotherapy can improve the OS of ES-SCLC. 270 participants will randomly receive 4-6 cycles (21daysper cycle)of chemotherapy plus TCM granules or placebo. The primary outcome measures is OS. The secondary outcome measures includesprogression-free survival(PFS), objective response rate(ORR), quality of life(QoL) and tumor markers. Visits will be performed at the end of each cycle during the treatment period and then every 3 months in the follow-up period until the patients’ death or study completion. Conclusion: the study’s result will provide a high-level evidence for TCM granules using with chemotherapy on the first-line treatment of ES-SCLC. Trial registration: Chinese Clinical Trial Registry, No. ChiCTR1900022991, registered 6 May 2019 (prospective registration).