NCT07362979

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 243 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 enrolled patients will be 1:1:1 randomly assigned to receive induction chemotherapy of Gemcitabine plus Cisplatin plus Toripalimab(GP plus Toripalimab regimen), Nab-paclitaxel plus Cisplatin plus Toripalimab (TP plus Toripalimab regimen) or Nab-paclitaxel plus Cisplatin plus Capecitabine plus Toripalimab(TPC plus Toripalimab regimen).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.

Conditions

• Nasopharyngeal Cancinoma (NPC)

Interventions

Type	Name	Description
DRUG	GP 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).
DRUG	TP 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).
DRUG	TPC 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).

Timeline

• Start date: 2026-03-12
• Primary completion: 2029-03-12
• Completion: 2031-03-12
• First posted: 2026-01-23
• Last updated: 2026-03-17

Locations

4 sites across 1 country: China