OncoMatch/Clinical Trials/NCT07328841
Reduced-dose Versus Conventional-dose Intensity-modulated Radiation Therapy for Locally Advanced Nasopharyngeal Carcinoma With Remission After Induction Chemotherapy and Immunotherapy
Is NCT07328841 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Full course of PD-1blockades and Cisplatin-based induction chemotherapy for nasopharyngeal carcinoma (npc).
Treatment: Full course of PD-1blockades · Cisplatin-based induction chemotherapy · Concurrent Chemotherapy — To explore the efficacy and safety of reduced-dose radiotherapy combined with concurrent chemotherapy and immunotherapy in stage Ⅳa (AJCC 8th,) locally advanced nasopharyngeal carcinoma patients who are sensitive to induction chemoimmunotherapy (assessed as complete response \[CR\]/partial response \[PR\] by imaging, with EBV DNA copy number reduced to zero or below the lower limit of detection), so as to provide a new treatment option for these patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: EBV DNA reduced to zero or below the lower limit of detection (zero or below lower limit of detection)
EBV DNA reduced to zero or below the lower limit of detection
Disease stage
Required: Stage T4N0-2M0, T1-4N3M0 (AJCC 8th and 9th edition)
AJCC 8th edition staging: T4N0-2M0, T1-4N3M0 (stage IVa); AJCC 9th edition staging: T4N0-2M0, T1-4N3M0 (stage III)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy — induction
After 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment
Must have received: immunotherapy — induction
After 3 courses of platinum-based chemotherapy combined with immunotherapy as induction treatment
Cannot have received: chemotherapy
Exception: excluding diagnostic treatment
Patients who have received any of the following for primary lesions and/or cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment)
Cannot have received: immunotherapy
Exception: excluding diagnostic treatment
Patients who have received any of the following for primary lesions and/or cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment)
Cannot have received: targeted therapy
Exception: excluding diagnostic treatment
Patients who have received any of the following for primary lesions and/or cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment)
Cannot have received: surgical treatment
Exception: excluding diagnostic treatment
Patients who have received any of the following for primary lesions and/or cervical metastatic lesions: chemotherapy, immunotherapy, targeted therapy, or surgical treatment (excluding diagnostic treatment)
Cannot have received: anti-PD-1 therapy
Patients with previous use of anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways
Cannot have received: anti-PD-L1 therapy
Patients with previous use of anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways
Cannot have received: anti-CTLA-4 therapy
Patients with previous use of anti-PD-1/PD-L1 antibodies, anti-CTLA-4 antibodies, or any other antibodies acting on T-cell costimulatory or checkpoint pathways
Lab requirements
Blood counts
White blood cell count ≥ 4000/μL, neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100000/μL
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Liver function
Bilirubin ≤ 1.5 × ULN (Gilbert's disease ≤ 3 × ULN); AST and ALT ≤ 1.5 × ULN; alkaline phosphatase ≤ 1.5 × ULN; albumin ≥ 3 g/dL
Adequate organ function: Hematology: White blood cell count ≥ 4000/μL, neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelet count ≥ 100000/μL; Liver function: Bilirubin ≤ 1.5 × ULN (Gilbert's disease ≤ 3 × ULN), AST and ALT ≤ 1.5 × ULN, alkaline phosphatase ≤ 1.5 × ULN; albumin ≥ 3 g/dL; Renal function: Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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