Phase 3 Trial of Adaptive Immunotherapy and Radiotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma

What this Trial Is About

Researchers are evaluating adaptive immunotherapy strategies for patients with locoregionally advanced nasopharyngeal carcinoma NPC. The study aims to compare whether radiotherapy alone is no worse than combined chemoradiotherapy in low-risk patients who respond well to initial treatment and have undetectable Epstein-Barr virus EBV DNA in their blood. For high-risk patients with stable disease or detectable EBV DNA after induction therapy, the study assesses whether adding capecitabine and immunotherapy after chemoradiotherapy improves event-free survival. The trial includes four treatment groups low-risk patients receive either radiotherapy alone or concurrent chemoradiotherapy high-risk patients receive either adjuvant capecitabine plus immunotherapy or immunotherapy alone following concurrent chemoradiotherapy. Capecitabine is given as a metronomic dose of 650 mgm twice daily for one year. Immunotherapy with Toripalimab is administered every three weeks. Induction chemoimmunotherapy is completed before randomization. The study is a randomized, controlled, multicenter phase 3 trial. Participants will be monitored for event-free survival and treatment-related nausea over three years. Assessments include overall survival, relapse-free survival, distant metastasis-free survival, adverse event monitoring, and quality-of-life evaluations using standardized questionnaires. Safety and treatment tolerability are regularly assessed. The total study duration includes treatment and follow-up periods extending up to three years to capture long-term outcomes and side effects.

Adaptive Immunotherapy for Nasopharyngeal Carcinoma