Phase 2 Study of Adebrelimab with Chemoradiotherapy for High-risk Locally Advanced Nasopharyngeal Cancer

What this Trial Is About

Researchers are evaluating the role of Adebrelimab combined with induction chemotherapy plus concurrent chemoradiotherapy ICCCRT for patients with high-risk locoregionally advanced nasopharyngeal carcinoma LANPC, specifically those with stage IVAT3N2M0 disease. This phase 2, multicenter, single-arm clinical trial aims to study treatment outcomes including failure-free survival over 3 years. Participants receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin every 3 weeks before radiation treatment. Concurrent cisplatin is given during intensity-modulated radiotherapy IMRT which delivers a total dose of 6996 cGy in 33 fractions. Adebrelimab, a PD-L1 antibody, is administered at 1200 mg every 3 weeks starting on day 1 of induction chemotherapy and continues for 3 cycles during induction and 9 cycles during adjuvant chemotherapy. During the study, participants will undergo multiple assessments including monitoring for adverse events, quality of life evaluations, and measurements of overall survival, distant metastasis-free survival, and locoregional recurrence-free survival over 3 years. Researchers will track failure-free survival as the primary outcome. The study includes regular follow-up visits to assess treatment effects and safety during and after therapy.

Adebrelimab and Chemoradiotherapy in High-risk LANPC