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OncoMatch/Clinical Trials/NCT07333274

Compare Radiotherapy Plus Nimotuzumab Versus Radiotherapy Alone in Platinum-ineligible Patients With Locoregionally Advanced Head and Neck Squamous Cell Carcinoma

Is NCT07333274 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Nimotuzumab for head & neck squamous cell carcinoma.

Phase 3RecruitingShandong Cancer Hospital and InstituteNCT07333274Data as of May 2026

Treatment: NimotuzumabThis is an open-label, prospective, randomized, Phase III, international multicenter clinical study to compare radiotherapy plus nimotuzumab versus radiotherapy alone in platinum-ineligible patients with locoregionally advanced head and neck squamous cell carcinoma (LA-HNSCC),

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Extracted eligibility criteria

Biomarker criteria

Required: EGFR testing required if tissue available (testing required; no eligibility threshold specified)

Provide tumor tissue, whenever possible, for EGFR testing

Required: HPV testing required for oropharyngeal cancer if tissue available (testing required; no eligibility threshold specified)

for oropharyngeal cancer, provide tissue for HPV/p16 testing if feasible

Disease stage

Required: Stage III, IVA, IVB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: pd-1 inhibitor

Exception: within 4 weeks prior to enrollment

Cannot have received: egfr monoclonal antibody

Exception: within 4 weeks prior to enrollment

Cannot have received: egfr tyrosine kinase inhibitor

Exception: within 4 weeks prior to enrollment

Cannot have received: anti-angiogenic agent

Exception: within 4 weeks prior to enrollment

Lab requirements

Blood counts

wbc ≥4×10^9/l; absolute neutrophil count ≥1.5×10^9/l; platelets ≥100×10^9/l; hemoglobin ≥90 g/l

Kidney function

serum creatinine ≤1.5×uln or crcl ≥60 ml/min (cockcroft-gault)

Liver function

total bilirubin ≤1.5×uln; ast ≤2.5×uln; alt ≤2.5×uln

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

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