OncoMatch/Clinical Trials/NCT05340491
Chemoradiotherapy Plus Anti-PD1 in Recurrent NPC: A Multicenter, Open-label, Randomised, Controlled, Phase III Trial
Is NCT05340491 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Toripalimab and Chemotherapy for nasopharyngeal carcinoma.
Treatment: Toripalimab · Chemotherapy — This is a multicenter, open-label, randomized, controlled, phase III trial. The purpose of this trial is to evaluate the efficacy and toxicity of anti-PD-1 antibody combined with chemoradiotherapy versus chemoradiotherapy alone in recurrent nasopharyngeal carcinoma patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage RII, RIII, RIVA
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: radiotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: chemotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: immunotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: biotherapy
No treatment to rNPC prior, such as radiotherapy, chemotherapy, immunotherapy or biotherapy
Cannot have received: anti-tumor Chinese medicine treatment
Treated with anti-tumor Chinese medicine treatment
Cannot have received: PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway
Have previously treated with PD-1 antibody or other immunotherapy for PD-1/PD-L1 pathway
Lab requirements
Blood counts
WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L
Kidney function
BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula)
Liver function
ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN
Adequate marrow function: WBC count ≥ 3×10E9/L, NE count ≥ 1.5×10E9/L, HGB ≥ 90g/L, PLT count ≥ 100×10E9/L; Adequate liver function: ALT/AST ≤ 2.5×ULN, TBIL ≤ 2.0×ULN; Adequate renal function: BUN/CRE ≤ 1.5×ULN or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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