Consolidation of Toripalimab and Capecitabine After Chemoradiotherapy in ESCC (EC-CRT-008)

NCT07177794 PHASE3 NOT_YET_RECRUITING

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.

Details

Lead sponsor	Sun Yat-sen University
Phase	PHASE3
Status	NOT_YET_RECRUITING
Enrolment	242
Start date	Sat Sep 20 2025 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri May 31 2030 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Esophageal Cancer
• Chemoradiotherapy

Interventions

• toripalimab
• capecitabine

Countries

China