Single-Arm Exploratory Study of PD-L1 Antibody Plus Neoadjuvant Chemotherapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
Trial Parameters
Brief Summary
This 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.
Eligibility Criteria
Inclusion Criteria: * 1\. Patients with head and neck squamous cell carcinoma diagnosed by histology or cytology; * 2\. Have not received systematic treatment for head and neck squamous cell carcinoma in the past; * 3\. According to the AJCC TNM staging system, it is divided into stages III-IVB; * 4\. ECOG score: 0-1 point; * 5\. Expected survival period ≥ 12 weeks; * 6\. The main organ functions well and the laboratory test data meets the following standards: (1) Blood routine: absolute neutrophil count ≥ 1.5 × 109/L (or greater than the lower limit of normal laboratory values in the research center), platelet count ≥ 100 × 109/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); * 7\. Female subjects with fertility, as we