drugset / Trial / NCT06900218

PD-1 Antibody Sintilimab Combined With Capecitabine as Adjuvant Therapy for High-Risk Nasopharyngeal Carcinoma

NCT06900218

Phase 3 Not yet recruiting 664 enrolled Sun Yat-sen University
RandomizedParallel-groupSingle-blindTreatment

Summary

This study will enroll 664 patients who had completed induction chemotherapy combined with the PD-1 antibody sintilimab treatment followed by concurrent cisplatin-based chemoradiotherapy (no concurrent sintiliamb). Patients will be randomly divided into two groups. One group will receive 9 cycles of sintilimab therapy, while the other group will receive an additional year of capecitabine chemotherapy on top of the sintilimab treatment. The primary endpoints will be event-free survival and overall survival.

Timeline

Start
2025-05-01
Primary completion
2030-05-01
Completion
2033-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 650 mg/m2 Oral
Background Sintilimab Monoclonal antibody 200 mg