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OncoMatch/Clinical Trials/NCT07055841

Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma

Is NCT07055841 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Adebrelimab and TP regimen for squamous cell carcinoma of head and neck.

Phase 2RecruitingXiuping DingNCT07055841Data as of May 2026

Treatment: Adebrelimab · TP regimenThis single-arm exploratory study plans to enroll 69 locally advanced head and neck squamous cell carcinoma (LA-HNSCC) patients. Participants will receive Adebrelimab (PD-L1 antibody) plus TP regimen (docetaxel/cisplatin) as neoadjuvant therapy for 1-4 weeks, followed by surgery and subsequent follow-up phase.

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Disease stage

Required: Stage III, IVB

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

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

Cannot have received: paclitaxel (paclitaxel)

Patients who have received previous treatment with paclitaxel drugs

Cannot have received: anti-tumor therapy

Exception: within 2 weeks prior to the first use of the investigational drug

Received anti-tumor therapy (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 2 weeks prior to the first use of the investigational drug

Cannot have received: investigational drug

Exception: within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug

Received any other investigational drug within 4 weeks prior to the first use of the investigational drug or had a half-life of no more than 5 from the last investigational drug

Cannot have received: anti-tumor vaccine

Exception: within 4 weeks prior to the first administration of the study drug

Individuals who have received anti-tumor vaccines or have received live vaccines within 4 weeks prior to the first administration of the study drug

Cannot have received: major surgery

Exception: within 4 weeks prior to the first use of the investigational drug

Having undergone major surgery or suffered severe trauma within 4 weeks prior to the first use of the investigational drug

Lab requirements

Blood counts

absolute neutrophil count ≥ 1.5 × 10^9/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90g/L

Kidney function

CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula)

Liver function

serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN

The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 10^9/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90g/L; (2) Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the standard value (ULN), AST and ALT ≤ 2.5 times ULN. If the patient has liver metastasis, this standard is ≤ 5 times ULN; (3) Renal function: CrCl ≥ 60 ml/min/1.73 m2 (calculated according to the Cockcroft Gault formula)

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

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