OncoMatch/Clinical Trials/NCT06092957
Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy
Is NCT06092957 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Cisplatin-based induction chemotherapy and Full course of PD-1/PD-L1 blockades for nasopharyngeal carcinoma.
Treatment: Cisplatin-based induction chemotherapy · Full course of PD-1/PD-L1 blockades · Concurrent Chemotherapy — This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: EBV DNA load = 0 copies/mL (or lower than the test line) (0 copies/mL (or lower than the test line))
EBV DNA load =0 copies/mL (or lower than the test line) after 3 cycles of induction therapy
Disease stage
Required: Stage III, IVA
Excluded: Stage T3N0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: platinum-based chemotherapy plus immunotherapy — induction
after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy
Cannot have received: chemotherapy
Exception: induction therapy as specified
Patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment)
Cannot have received: immunotherapy
Exception: induction therapy as specified
Patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment)
Cannot have received: targeted therapy
Patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment)
Cannot have received: surgery
Exception: diagnostic treatment
Patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment)
Cannot have received: anti-PD-1 antibody
Subjects who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs
Cannot have received: anti-PD-L1 antibody
Subjects who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs
Cannot have received: anti-CTLA-4 antibody
Subjects who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs
Cannot have received: anti-angiogenic drugs
Subjects who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs
Lab requirements
Blood counts
neutrocyte count≥4×10e9/L, hemoglobin ≥90g/L, platelet count ≥100×10e9/L
Kidney function
creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5×ULN
Liver function
ALT/AST ≤2.5×ULN, bilirubin ≤2.5×ULN
Adequate marrow function: neutrocyte count≥4×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L. Adequate liver and kidney function: ALT/AST ≤2.5×ULN, bilirubin ≤2.5×ULN; creatinine clearance rate ≥ 60 ml/min or creatinine ≤ 1.5×ULN.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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