OncoMatch/Clinical Trials/NCT04453826
Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma
Is NCT04453826 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Demographics
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.
Frequently asked questions
Is NCT04453826 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior PD-1 therapy, systematic glucocorticoid therapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage T4N0-2M0 or T1-4N3M0 (STAGE IVA) or T1-3N1-2M0 or 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 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages