Clinical Trial

Efficacy and Safety of TPC Induction Chemotherapy Combined With Nimotuzumab and Toripalimab "Immune Sandwich" Regimen Versus Full-Course Immunotherapy for Locally Advanced Nasopharyngeal Carcinoma

Recruiting Phase 3
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Summary
Immunotherapy combined with chemoradiotherapy has become standard care for locally advanced nasopharyngeal carcinoma, yet radiotherapy-induced lymphopenia may impair the efficacy of concurrent PD-1 blockade. Existing evidence supports synergistic anti-tumor activity between the anti-EGFR antibody nimotuzumab and toripalimab. This multicenter, open-label, non-inferiority Phase III trial randomizes eligible stage III-IVA LA-NPC patients 1:1 to two arms. The experimental group receives an "immune sandwich" regimen: TPC induction plus nimotuzumab and toripalimab, concurrent radiotherapy with weekly nimotuzumab only, followed by toripalimab maintenance. The control arm adopts full-course toripalimab throughout induction, concurrent radiotherapy and adjuvant phases. The primary endpoint is 3-year event-free survival, with secondary endpoints covering overall survival, local/distant control rates, objective response rate and treatment-related toxicities. A total of 566 subjects will be enrolled to verify whether the simplified sandwich strategy delivers non-inferior survival with better safety profiles.
Trial Details
NCT Number NCT07706985
Lead Sponsor Sun Yat-sen University
Collaborators: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Conditions Nasopharyngeal Carcinoma (NPC)
Enrollment 566 participants
Start Date 2026-07-20
Primary Completion 2030-07-20 (estimated)
Study Completion 2033-07-20 (estimated)
Updated on ClinicalTrials.gov 2026-07-16