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

This study explored the efficacy of adelbelimab (PD-L1 inhibitor) combined with chemotherapy in preoperative induction chemotherapy in patients with locally advanced head and neck squamous cell carcinoma

Sex

All

Minimum age

18 Years

Maximum age

75 Years

Inclusion Criteria:

1. Age between 18-75 years old
2. 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
3. Resectable tumors were evaluated by head and neck surgeons before enrollment to exclude clinical evidence of distant metastasis
4. According to RECIST 1.1, there is at least one measurable tumor lesion
5. The performance status of the Eastern Cooperative Oncology Group (ECOG) is 0-1
6. 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).
7. 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.
8. 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.
9. 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
10. Have not participated in other clinical trial projects in the past 30 days;
11. Patients who voluntarily participate in the project and sign the informed consent.

Exclusion Criteria:

1. The patient has abnormal blood indicators, abnormal liver and kidney function, and cannot tolerate the clinical research process after multidisciplinary consultation evaluation
2. The patient has previously suffered from other tumors, or has previously undergone anti-tumor treatments such as surgery, chemotherapy, and radiotherapy
3. The entire clinical research process cannot be completed due to personal, social and economic reasons
4. Serious systemic diseases in the past and the diseases cannot be cured or controlled by drugs -

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