Adelbelimab Combination Chemotherapy in Neoadjuvant Therapy for Squamous Cell Carcinoma of the Head and Neck

Korábbi kezelés

• The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy

Más betegség

• Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -

Egyéb

• The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
• The entire clinical research process cannot be completed due to personal, social and economic reasons

• Age between 18-75 years old
• According to the 8th edition of the guidelines of the American Joint Committee on Cancer (AJCC), patients with stage III-IVB tumors of non-oropharyngeal cancers confirmed by pathology as head and neck squamous cell carcinoma (oral cavity, oropharynx, hypopharynx or larynx) and HPV-negative oropharyngeal cancer patients, or HPV-positive oropharyngeal cancer patients with stage II-III tumors
• Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
• According to RECIST 1.1, there is at least one measurable tumor lesion
• The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1
• Blood routine: white blood cell count (WBC) ≥ 3.0×109/L; absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL (without corresponding supportive treatment such as blood transfusion and leukocytosis within 7 days).
• Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients without liver metastasis ≤ 2.5 times the upper limit of the reference value (ULN); albumin (ALB) ≥ 30 g /L.
• Renal function: serum creatinine ≤ 1.5 times ULN or creatinine clearance (CrCl) ≥ 50mL/min (using the Cockcroft/Galter formula); urine protein (UPRO) < (++), or 24 Hourly urine protein < 1.0 g.
• Determination of HPV status in oropharyngeal cancers using p16 IHC. A sample was considered p16 positive if >70% of tumor cells exhibited intense diffuse nuclear and cytoplasmic staining
• Have not participated in other clinical trial projects in the past 30 days;
• Patients who voluntarily participate in the project and sign the informed consent.