Maintenance Therapy With Toripalimab and Capecitabine Versus Capecitabine Alone in High-risk Nasopharyngeal Carcinoma

N3 classification, rENE positivity is a high-risk type of locally advanced nasopharyngeal carcinoma. EBV DNA remaining at detectable levels after induction chemotherapy is also a characteristic of high-risk nasopharyngeal carcinoma. Based on the available evidence, patients with high-risk nasopharyngeal carcinoma are recommended to receive oral maintenance therapy to reduce the risk of failure. The purpose of this study was to conduct a prospective, multicenter, randomized phase III clinical trial to determine whether maintenance therapy with triprilimab combined with capecitabine is better than maintenance therapy with capecitabine alone in high-risk nasopharyngeal carcinoma (N3+, rENE+, Detectable EBV DNA after 2 cycles of induction chemotherapy).

NCT Number	NCT06277050
Lead Sponsor	Jiangxi Provincial Cancer Hospital
Conditions	Nasopharyngeal Carcinoma, High-Risk Cancer, Maintenance Therapy
Enrollment	264 participants
Start Date	2024-03-07
Primary Completion	2030-02-20 (estimated)
Study Completion	2031-02-20 (estimated)
Updated on ClinicalTrials.gov	2026-05-15