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OncoMatch/Clinical Trials/NCT06444009

A Phase II Study of Neoadjuvant Immunotherapy in Combination With Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Is NCT06444009 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Ivonescimab combined with TP and Cadonilimab combined with TP for head and neck squamous cell carcinoma.

Phase 2RecruitingLei LiuNCT06444009Data as of May 2026

Treatment: Ivonescimab combined with TP · Cadonilimab combined with TP · Penpulimab combined with TPA Randomized, Phase II Study of ivonescimab or cadonilimab or penpulimab in Combination With Cisplatin and Nab-paclitaxel in Patients With locally advanced head and neck squamous cell carcinoma (HNSCC) eligible for resection. This proposed study will evaluate the efficacy and safety of preoperative administration of ivonescimab or cadonilimab or penpulimab combined with chemotherapy in HNSCC who are eligible for resection.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: any anti-tumor treatment

Lab requirements

Blood counts

total white blood cell count ≥ 3.0×10^9/l, absolute lymphocyte count ≥ 0.8×10^9/l, absolute neutrophil count ≥ 1.5×10^9/l, platelets ≥ 100×10^9/l, hemoglobin ≥ 90g/l

Kidney function

serum creatinine ≤ 1.5 times uln or calculated creatinine clearance ≥ 60 ml/min (cockcroft-gault formula), urine protein <2+ on dipstick or <1g in a 24-hour urine collection

Liver function

bilirubin level ≤ 2 times the upper limit of normal (uln); aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels ≤ 2.5 times uln

Cardiac function

normal or clinically insignificant abnormalities on electrocardiogram (ecg), echocardiogram showing a left ventricular ejection fraction (lvef) ≥50%

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

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