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OncoMatch/Clinical Trials/NCT06345287

Response Adaptive Radiotherapy Following Immunotherapy-based Induction for Non-HPV Related HNSCC

Is NCT06345287 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies anti-PD-1 or PD-L1 antibody for head and neck cancer.

Phase 2RecruitingCancer Institute and Hospital, Chinese Academy of Medical SciencesNCT06345287Data as of May 2026

Treatment: anti-PD-1 or PD-L1 antibodyThe aim of this study is to develop an adaptive radiation therapy plan for locally advanced head and neck squamous cell carcinoma receiving induction therapy containing immunotherapy and chemotherapy. The therapy plan is based on clinical remission, in order to reduce treatment-related toxic side effects without sacrificing clinical efficacy and improve the quality of life of patients.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Biomarker criteria

Required: HPV negative

HPV or P16 (-)

Required: CDKN2A P16 negative

HPV or P16 (-)

Disease stage

Required: Stage T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition)

Clinical staging is T1-2N2-3M0, T3-4N0-3M0 (AJCC 8th edition); ... surgery is not recommended to preserve organ function, or the patient refuses surgery

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: chemotherapy — induction

undergo 2-4 cycles of induction chemotherapy

Must have received: immunotherapy — induction

undergo 2-4 cycles of induction ... immunotherapy

Cannot have received: anti-PD-1 therapy

Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

Cannot have received: immunotherapy targeting PD-1/PD-L1

Previously received other PD-1 antibody treatments or other immunotherapies targeting PD-1/PD-L1

Lab requirements

Blood counts

WBC ≥ 3.0 × 10^9/L, ANC ≥ 2.0 × 10^9/L, PLT ≥ 100 × 10^9/L, HGB ≥ 90g/L (no blood transfusion or blood products within 14 days, no use of G-CSF or other hematopoietic stimulating factors correction)

Kidney function

BUN and CRE ≤ 1.5 × ULN, or endogenous creatinine clearance rate ≥ 60ml/min (Cockcroft Gout formula)

Liver function

TBIL ≤ 2.0 × ULN, ALT, AST ≤ 2.5 × ULN

Cardiac function

Good coagulation function: INR or PT ≤ 1.5 × ULN; myocardial enzyme spectrum is within the normal range

The functional level of the main organs meets the following standards: ... blood routine examination ... biochemical examination ... coagulation function ... myocardial enzyme spectrum

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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