drugset / Trial / NCT06900218
PD-1 Antibody Sintilimab Combined With Capecitabine as Adjuvant Therapy for High-Risk Nasopharyngeal Carcinoma
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 650 mg/m2 | Oral |
| Background | Sintilimab | Monoclonal antibody | 200 mg | — |