RecruitingPhase 2NCT07362979

Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma

Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma: A Randomized, Open-label, Controlled, Multicenter Phase II Trial

Sponsor

Sun Yat-sen University

Enrollment

243 participants

Start Date

Mar 12, 2026

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancinoma (NPC)

Summary

This phase II randomized trial compares the efficacy and safety of Toripalimab combined with three different platinum-based induction chemotherapy regimens, sequentially followed by standard concurrent chemoradiotherapy, for the treatment of locally advanced nasopharyngeal carcinoma (NPC). The study is aimed to pick up the most effective platinum-based induction chemotherapy regimen plus Toripalimab for these patients which provides the most survival benefit.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different platinum-based chemotherapy combinations, both given alongside an immunotherapy drug called toripalimab, for treating locally advanced nasopharyngeal carcinoma — a type of head and neck cancer. The goal is to find which combination works better before radiation therapy. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with nasopharyngeal carcinoma (a specific type of head and neck cancer) confirmed by biopsy - Your cancer has not spread to other parts of the body (no distant metastases) - You are in good overall health and your blood counts and organ function are within normal ranges **You may NOT be eligible if...** - Your cancer has spread beyond the head and neck region - You have a serious autoimmune condition or are on immunosuppressive medications - You have active hepatitis B or C, or HIV - You are pregnant or breastfeeding - You have previously received chemotherapy or radiation for this cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGP plus Toripalimab Induction chemotherapy+CCRT

Induction Chemotherapy + Immunotherapy (3 Cycles): Gemcitabine 1000mg/m\^2 (Days 1, 8) + Cisplatin 80mg/m\^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m\^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy).

DRUGTP plus Toripalimab Induction chemotherapy+CCRT

Induction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 260mg/m\^2 (Days 1) + Cisplatin 75mg/m\^2 (Day 1) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m\^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy).

DRUGTPC plus Toripalimab Induction chemotherapy+CCRT

Induction Chemotherapy + Immunotherapy (3 Cycles): Nab-paclitaxel 200mg/m\^2 (Days 1) + Cisplatin 75mg/m\^2 (Day 1) + Capecitabine 1000mg/m\^2 BID (Day 1-Day14) + Toripalimab 240mg (Day 1), administered every 3 weeks for a total of 3 cycles. Sequentially followed by Concurrent Chemoradiotherapy (CCRT): Cisplatin 100mg/m\^2 (Day 1), administered every 3 weeks for a total of 3 cycles during the radiotherapy period (on Days 1, 22, and 43 of radiotherapy).