OncoMatch/Clinical Trials/NCT04453826
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Is NCT04453826 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Camrelizumab plus chemo-radiotherapy and Chemo-radiotherapy alone for nasopharyngeal cancer.
Treatment: Camrelizumab plus chemo-radiotherapy · Chemo-radiotherapy alone — Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Disease stage
Required: Stage T4N0-2M0, T1-4N3M0 (STAGE IVA), T1-3N1-2M0, T2-3N0M0 (STAGE II-III) WITH SD/PD ACCORDING TO RECIST CRITERIA OR EBV DNA OF >0 COPIES/ML AFTER 3 CYCLES OF GP INDUCTION CHEMOTHERAPY (8th AJCC edition)
Excluded: Stage STAGE II-III EVALUATED AS PR OR CR AND EBV DNA OF 0 COPIES/ML AFTER 3 CYCLES OF GP INDUCTION CHEMOTHERAPY, RECURRENT OR METASTATIC NASOPHARYNGEAL CARCINOMA
Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition). Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy.
Prior therapy
Must have received: GP induction chemotherapy — induction
after 3 cycles of GP induction chemotherapy
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: systematic glucocorticoid therapy
Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication
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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