NCT06900218

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

A Multicenter, Randomized Controlled Phase III Trial of Sintilimab Combined With Capecitabine Versus Capecitabine Alone as Adjuvant Therapy for High-Risk Locoregionally-advanced Nasopharyngeal Carcinoma

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 664 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nasopharyngeal Carcinoma (NPC)

Interventions

Type	Name	Description
DRUG	Sintilimab	Sintilimab 200 mg, administered on Day 1, every 3 weeks for a total of 9 cycles
DRUG	Capecitabine	Capecitabine 650 mg/m², taken orally twice daily, continuously from Day 1 to Day 21, every 3 weeks, for a maximum of 1 year.

Timeline

• Start date: 2025-05-01
• Primary completion: 2030-05-01
• Completion: 2033-05-01
• First posted: 2025-03-28
• Last updated: 2025-04-02

Locations

1 site across 1 country: China