Phase III Trial of Toripalimab Plus Capecitabine as Maintenance After Chemoradiotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

What this Trial Is About

Researchers are investigating a new approach to improve treatment outcomes for patients with locally advanced esophageal squamous cell carcinoma ESCC who have not progressed after definitive chemoradiotherapy CRT. The study evaluates whether adding toripalimab combined with metronomic capecitabine as maintenance therapy can reduce the high recurrence rate following CRT. This phase III, randomized, controlled, multicenter trial builds on previous findings suggesting that toripalimab with CRT improves response rates and may enhance long-term survival with manageable side effects. Participants in the trial will be randomly assigned to one of two groups one receiving toripalimab intravenously at 240 mg every three weeks for up to 16 cycles combined with oral capecitabine at 500 mg twice daily for up to one year, and the other undergoing regular observation and follow-up without additional treatment. The study treatment period lasts a maximum of one year, during which the combination therapys safety and efficacy are closely monitored. Throughout the trial, participants will undergo regular assessments, including monitoring for disease progression, survival status, treatment-related adverse events, and clinical complete response approximately 14 to 16 weeks after radiotherapy completion. Progression-free survival will be evaluated up to 36 months from enrollment, with overall survival and safety also tracked for the same duration. The study aims to provide detailed information on the benefits and risks of this maintenance therapy approach for ESCC patients after CRT.

Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC