Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma: A Prospective, Single-Arm Clinical Study

Ki vehet részt

• Age 18-75 years
• Histologically or cytologically confirmed resectable stage III-IVB head and neck squamous cell carcinoma (HNSCC) of the oral cavity, oropharynx, hypopharynx, or larynx according to the AJCC 9th edition
• For oropharyngeal cancer, tumor tissue must be available for HPV/P16 testing (testing is not required if previously performed)
• Tumor tissue (from the primary tumor or resected tumor) must be available for EGFR and PD-L1 immunohistochemical testing (testing is not required if previously performed); genetic testing may be performed when necessary
• ECOG performance status 0-1
• At least one measurable lesion according to RECIST 1.1
• Expected survival ≥6 months
• Adequate hematologic function: white blood cell count ≥3 × 10\^9/L; absolute neutrophil count ≥1.5 × 10\^9/L; platelet count ≥100 × 10\^9/L; hemoglobin ≥90 g/L
• Adequate renal function: serum creatinine ≤1.5 × ULN or creatinine clearance (CrCl) >50 mL/min (using the Cockcroft-Gault formula):
• Female CrCl = (140 - age) × body weight (kg) × 0.85 / (72 × Scr mg/dL); Male CrCl = (140 - age) × body weight (kg) × 1.00 / (72 × Scr mg/dL)
• Adequate hepatic function: total serum bilirubin ≤1.5 × ULN; aspartate aminotransferase (AST) ≤2.5 × ULN; alanine aminotransferase (ALT) ≤2.5 × ULN
• Women of childbearing potential must have a negative pregnancy test within 2 weeks before the start of study treatment and must not be breastfeeding. -Female participants must agree to use effective contraception during the study and for 6 months after the last dose of study drug. Male participants must agree to use effective contraception during the study and for 6 months after the last dose of study drug
• Participants must voluntarily agree to participate, provide written informed consent, and be able to comply with the study visits and procedures specified in the protocol

Ki nem vehet részt

• Treatment with systemic or local corticosteroids within 4 weeks before enrollment
• Participation in another interventional clinical trial within 30 days before screening
• Presence of poorly controlled concomitant diseases (e.g., heart failure, severe pulmonary disease, severe liver disease, psychiatric disorders, etc.)
• Major surgery within 90 days before the first dose of study drug or planned surgery
• Unwillingness to participate in the study or inability to sign informed consent; Receipt of a live vaccine within 30 days before study drug administration
• HIV-positive; HBsAg-positive with detectable HBV DNA (quantitative ≥1000 copies/mL); or positive blood screening for chronic hepatitis C (HCV antibody-positive) with detectable HCV RNA
• History of other malignancies (except cured basal cell carcinoma of the skin). History of primary immunodeficiency
• Known allergy to any study drug or its components
• Any condition that, in the investigator's opinion, makes the participant unsuitable for the study
• Prior radiotherapy or chemotherapy; prior immunotherapy targeting PD-1/PD-L1; prior EGFR monoclonal antibody, EGFR-TKI, or anti-angiogenic therapy
• Pregnancy (confirmed by blood or urine HCG) or breastfeeding; or participants of childbearing potential (both male and female) who are unwilling or unable to use effective contraception until at least 6 months after the last study treatment