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

NCT06900218 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 664

Last updated 2025-04-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06900218 on ClinicalTrials.gov