OncoMatch/Clinical Trials/NCT04453813
Toripalimab Plus Concurrent Chemo-radiotherapy for Unresectable Locally Recurrent Nasopharyngeal Carcinoma
Is NCT04453813 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Toripalimab plus concurrent chemo-radiotherapy and Concurrent chemo-radiotherapy for nasopharyngeal carcinoma.
Treatment: Toripalimab plus concurrent chemo-radiotherapy · Concurrent chemo-radiotherapy — Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to concurrent chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of patients with unresectable locally recurrent nasopharyngeal carcinoma compared with those treated with concurrent chemo-radiotherapy alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage RT2-4N0-3M0, RII-IVA (8th AJCC edition)
Excluded: Stage RT2 (THE TUMOUR IS CONFINED IN THE SUPERFICIAL PARAPHARYNGEAL SPACER AND IS MORE THAN 0.5CM FROM THE INTERNAL CAROTID ARTERY), RT3 (THE TUMOUR IS CONFINED IN THE BASE WALL OF THE SPHENOID SINUS AND IS MORE THAN 0.5CM FROM THE INTERNAL CAROTID ARTERY AND CAVERNOUS SINUS)
Tumor staged as rT2-4N0-3M0，rII-IVa (according to the 8th AJCC edition).
Prior therapy
Must have received: radiation therapy — definitive
The recurrence time is more than 12 months from the end of the first course of radiotherapy.
Cannot have received: PD-1 therapy
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
Cannot have received: anti-PD-L1 therapy
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
Cannot have received: anti-CTLA-4 therapy
Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
Lab requirements
Blood counts
normal bone marrow function
Kidney function
creatinine clearance rate of at least 60 ml/min or creatinine of no more than 1.5 times the upper normal limit
Liver function
total bilirubin, ast and alt levels of no more than 2.5 times the upper normal limit
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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