Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Ad… (NCT07362979) | Clinical Trial Compass
RecruitingPhase 2
Toripalimab Combined With Different Platinum-Based Induction Chemotherapy Regimens for Locally Advanced Nasopharyngeal Carcinoma
China243 participantsStarted 2026-03-12
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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).
✓. 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).
Exclusion criteria
✕. 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.