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OncoMatch/Clinical Trials/NCT07362979

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

Is NCT07362979 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including GP plus Toripalimab Induction chemotherapy+CCRT and TP plus Toripalimab Induction chemotherapy+CCRT for nasopharyngeal cancinoma (npc).

Phase 2RecruitingSun Yat-sen UniversityNCT07362979Data as of May 2026

Treatment: GP plus Toripalimab Induction chemotherapy+CCRT · TP plus Toripalimab Induction chemotherapy+CCRT · TPC plus Toripalimab Induction chemotherapy+CCRTThis 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.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage ANY T, N2-3, T4, N1 (AJCC 9th edition)

Excluded: Stage DISTANT METASTASIS (M1)

Stage Any T, N2-3 or T4, N1 (AJCC 9th edition staging), with no distant metastasis (M0). Patients with nasopharyngeal carcinoma presenting with recurrence or distant metastasis [excluded].

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: radiotherapy

Prior history of radiotherapy

Cannot have received: systemic chemotherapy

Prior history of systemic chemotherapy

Cannot have received: immune checkpoint inhibitor (CTLA-4 inhibitor, PD-1 inhibitor, PD-L1 inhibitor)

Patients previously treated with immune checkpoint inhibitors (e.g., CTLA-4, PD-1, PD-L1 inhibitors)

Cannot have received: anticancer monoclonal antibody

Exception: within 4 weeks prior

Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior

Cannot have received: immunosuppressive therapy

Exception: within 4 weeks prior

Patients who have received high-dose glucocorticoids, anticancer monoclonal antibodies, or other immunosuppressive therapy within 4 weeks prior

Lab requirements

Blood counts

Hemoglobin (HGB) ≥ 90g/L, Absolute Neutrophil Count (ANC) ≥ 1.5×10^9/L, and Platelet (PLT) ≥ 100×10^9/L

Kidney function

Serum creatinine ≤ 1.5×ULN or calculated creatinine clearance (CrCl) ≥ 60 mL/min (using the Cockcroft-Gault formula)

Liver function

ALT and AST ≤ 2.5×ULN, total bilirubin ≤ 2.0×ULN, and serum albumin ≥ 30g/L

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).

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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