Actively Recruiting
Phase III Study of Maintenance Therapy with Toripalimab plus Capecitabine Versus Capecitabine Alone in High-Risk Nasopharyngeal Carcinoma
Led by Jiangxi Provincial Cancer Hospital · Updated on 2026-05-15
264
Participants Needed
3
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating maintenance therapies for patients with high-risk nasopharyngeal carcinoma characterized by N3 classification, rENE positivity, or detectable EBV DNA after induction chemotherapy. This phase III clinical trial aims to compare whether combining toripalimab with capecitabine offers better outcomes than capecitabine alone for these patients. Participants are randomly assigned to one of two groups one receiving maintenance therapy with both toripalimab and capecitabine, and the other receiving only capecitabine. Capecitabine is given orally twice daily for 14 days every 3 weeks, while toripalimab is administered every 3 weeks. Both treatments continue for a total of 12 months. Throughout the study, participants undergo regular monitoring to assess disease progression and survival over three years. The primary measurement is progression-free survival at 3 years, with additional evaluations including distant metastasis-free survival, overall survival, and loco-regional recurrence-free survival. Patients will be assessed for safety and treatment adherence during their participation, which may last several years including long-term follow-up.
CONDITIONS
Brief Title
Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma
Research Team
J
Jingao Li, MD
X
Xiaochang Gong, MD
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