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.
Age between 18 and 70 years, male or non-pregnant female.
Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0).
ECOG performance status score of 0 or 1.
Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis.
Pathologically confirmed diagnosis of keratinizing squamous cell carcinoma (WHO Type I).
Prior history of radiotherapy or systemic chemotherapy.
Women who are pregnant, lactating, or of childbearing potential not employing effective contraception.
Parallel
GP plus Toripalimab Induction chemotherapy+CCRT
DrugInduction 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).
TP plus Toripalimab Induction chemotherapy+CCRT
DrugInduction 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).
TPC plus Toripalimab Induction chemotherapy+CCRT
DrugInduction 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).
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
Overall survival
The time from randomization to death from any cause or censored at the date of the last follow-up.
Local-Regional failure free survial
The time from randomization to documented local and/or regional recurrence, or death from any cause.
Distant metastasis-free survival
The time from randomization to distant metastasis or death from any cause.
Complete Response Rate
CR is assessed by independent reviewers after induction chemotherapy, according to the Response Evaluation Criteria in Solid Tumors Version 1.1(RECIST v1.1). Complete response is defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) . Complete response rate is defined as the percentage of evaluable patients achieving Complete Response following induction chemotherapy.
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