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OncoMatch/Clinical Trials/NCT06712888

Toripalimab Vs. Placebo Wtih GP Induction Chemotherapy in Locoregionally Advanced Nasopharyngeal Carcinoma

Is NCT06712888 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies TORIPALIMAB for nasopharyngeal carcinoma (npc).

Phase 3RecruitingSun Yat-sen UniversityNCT06712888Data as of May 2026

Treatment: TORIPALIMABThe main questions it aims to answer are: 1. Does the combination of GP induction chemotherapy and toripalimab improve the 3-year progression-free survival (PFS) compared to GP induction chemotherapy with placebo? 2. What are the differences in CR after induction therapy, 3-year overall survival (OS), locoregional progression, and distant progression between the two groups? 3. What are the differences in safety between the two groups? 4. Are there predictive biomarkers of therapeutic efficacy, such as changes in EBV DNA or immune parameters, that correlate with treatment outcomes? Researchers will compare the GP + toripalimab group with the GP + placebo group to see if the toripalimab combination shows superior efficacy. Participants will: Receive either GP chemotherapy with toripalimab or GP chemotherapy with placebo as induction therapy. Undergo concurrent chemoradiotherapy ± adjuvant metronomic capecitabine following induction therapy. Be monitored closely for safety and efficacy outcomes.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage ANY T, N2-3, T4N1 (9th AJCC/UICC)

Staging of any T, N2-3 or T4N1 (9th AJCC/UICC staging), with no distant metastasis.

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: radiotherapy

Cannot have received: systemic chemotherapy

Lab requirements

Blood counts

HGB ≥90 g/L, neutrocyte count ≥1.5×10⁹/L, PLT ≥100×10⁹/L

Kidney function

creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula)

Liver function

ALT and AST ≤2.5×ULN, bilirubin ≤1.5×ULN

Hemoglobin (HGB) ≥90 g/L, neutrocyte count≥1.5×10⁹/L, platelets (PLT) ≥100×10⁹ /L. ALT and AST≤2.5×ULN, bilirubin ≤ 1.5×ULN. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).

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

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