Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC

Definitive chemoradiotherapy (CRT) is the standard treatment for locally advanced unresectable esophageal cancer, but its efficacy remains unsatisfactory. More importantly, there is a lack of effective consolidation treatment after CRT, resulting in a high recurrence rate. Our previous prospective phase II trial (EC-CRT-001) demonstrated that the addition of toripalimab to definitive CRT improved the complete response rate in patients with locally advanced esophageal squamous cell carcinoma (ESCC), showing potential for enhanced long-term survival with a manageable safety profile. Nevertheless, the risk of recurrence requires further reduction. Metronomic capecitabine chemotherapy can modulate the tumor immune microenvironment and may synergize with PD-1 antibodies to enhance antitumor efficacy, potentially further prolonging survival in ESCC. Based on current research advances and our preliminary findings, this randomized, controlled, multicenter, phase III clinical trial aims to evaluate the efficacy and safety of toripalimab combined with capecitabine as maintenance therapy for patients with locally advanced ESCC who have not progressed after definitive CRT.

NCT Number	NCT07177794
Lead Sponsor	Sun Yat-sen University Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Fifth Affiliated Hospital, Sun Yat-Sen University, Zhongshan People's Hospital, Guangdong, China
Conditions	Esophageal Cancer, Chemoradiotherapy
Enrollment	242 participants
Start Date	2025-09-10
Primary Completion	2028-05-31 (estimated)
Study Completion	2030-05-31 (estimated)
Updated on ClinicalTrials.gov	2026-04-21