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RECRUITING
NCT07362979
PHASE2

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

Sponsor: Sun Yat-sen University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

243

Start Date

2026-03-12

Completion Date

2031-03-12

Last Updated

2026-03-17

Healthy Volunteers

No

Interventions

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).

Locations (4)

Dongguan People's Hospital

Dongguan, Guangdong, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen

Shenzhen, Guangdong, China

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, China