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Adaptive Immunotherapy for Nasopharyngeal Carcinoma
Sponsor: Sun Yat-sen University
Summary
1. To assess whether radiotherapy alone is non-inferior to concurrent chemoradiotherapy with respect to event-free survival and superior in reducing treatment-related nausea in low-risk locoregionally advanced nasopharyngeal carcinoma patients who achieve complete or partial response and undetectable serum EBV-DNA following induction chemoimmunotherapy. 2. To evaluate whether adjuvant capecitabine and immunotherapy after concurrent chemoradiotherapy improves event-free survival compared to adjuvant immunotherapy in high-risk locoregionally advanced nasopharyngeal carcinoma patients with stable disease or detectable serum EBV-DNA after induction chemoimmunotherapy.
Official title: Adaptive Immunotherapy for Locoregional Nasopharyngeal Carcinoma: a Randomized, Controlled, Multicenter, Phase 3 Clinical Trial
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
802
Start Date
2025-11-13
Completion Date
2033-09
Last Updated
2025-11-25
Healthy Volunteers
No
Conditions
Interventions
Radical radiotherapy of nasopharynx and neck
Radical radiotherapy of nasopharynx and neck
Capecitabine
Adjuvant metronomic capecitabine (650 mg/m² twice daily) for one year
Concurrent chemoradiotherapy (cCRT)
Concurrent chemoradiotherapy
Toripalimab
Adjuvant Toripalimab (240mg day1, Q3W )
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China