Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
1 other identifier
interventional
243
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2026
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
March 12, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 12, 2031
March 17, 2026
March 1, 2026
3 years
January 15, 2026
March 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
2 years
Secondary Outcomes (5)
Overall survival
2 years
Local-Regional failure free survial
2 years
Distant metastasis-free survival
2 years
Complete Response Rate
9 weeks
Incidence of Acute and Late Toxicity
2 years
Study Arms (3)
GP plus Toripalimab Induction chemotherapy
EXPERIMENTALInduction 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.
TP plus Toripalimab Induction chemotherapy
EXPERIMENTALInduction 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.
TPC plus Toripalimab Induction chemotherapy
EXPERIMENTALInduction 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.
Interventions
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).
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).
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).
Eligibility Criteria
You may qualify if:
- 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.
- Adequate hematological function: Hemoglobin (HGB)≥90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5\*10\^9/L, and Platele (PLT) ≥100\*10\^9/L.
- Adequate hepatic function: ALT and AST≤2.5\*Upper Limit of Normal (ULN), total bilirubin ≤2.0\*ULN, and serum albumin≥30g/L.
- Adequate renal function: Serum creatinine ≤ 1.5\*ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula).
- International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 \*ULN (unless the subject is receiving anticoagulant therapy and the coagulation parameters (PT/INR and APTT) are within the expected therapeutic range for the anticoagulant at the time of screening).
You may not qualify if:
- 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.
- HIV-positive status.
- History of other malignancies (except for cured basal cell carcinoma or carcinoma in situ of the cervix).
- Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors).
- Patients with immunodeficiency diseases or a history of organ transplantation.
- Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior.
- Patients with significantly impaired cardiac, hepatic, pulmonary, renal, or bone marrow function.
- Concurrent use of other investigational drugs or current participation in another clinical trial.
- Patients who refuse or are unable to provide signed informed consent for trial participation.
- Patients with personality or psychiatric disorders, or those lacking legal capacity or with limited legal capacity.
- Hepatitis B surface antigen (HBsAg) positive with peripheral blood Hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 1000 copies/ml.
- Patients with positive Hepatitis C virus (HCV) antibody test results are eligible only if the HCV ribonucleic acid (RNA) polymerase chain reaction test result is negative.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Department of Nasopharyngeal Carcinoma
Study Record Dates
First Submitted
January 15, 2026
First Posted
January 23, 2026
Study Start
March 12, 2026
Primary Completion (Estimated)
March 12, 2029
Study Completion (Estimated)
March 12, 2031
Last Updated
March 17, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share