A Prospective, Randomized Controlled, Phase II Clinical Study on the Neoadjuvant Treatment of Locally Advanced Resectable Head and Neck Squamous Cell Carcinoma With Tislelizumab Combined With Chemotherapy for Different Cycles (NeoTempo)
This study aims to explore the optimal course of neoadjuvant immunotherapy for HNSCC by comparing the efficacy and safety of 4 cycles and 2 cycles of neoadjuvant tislelizumab combined with chemotherapy.
• Histological or pathological diagnosis of head and neck squamous cell carcinoma;
• Initially resectable stage III-IVB oral cancer/laryngeal cancer/hypopharyngeal cancer/P16-oropharyngeal cancer, or stage III p16+ oropharyngeal cancer (AJCC 8th), and evaluated by the researcher to achieve R0 resection;
• Plan to perform neoadjuvant therapy;
• No previous anti-tumor treatment for HNSCC;
• There is at least one measurable lesion;
• Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2;
• The expected survival period is ≥3 months
• The functions of vital organs meet the following requirements (excluding any blood components and cell growth factors used within 7 days) :
• i. Normal bone marrow reserve function, white blood cell (WBC) ≥3.0×109/L; Neutrophil count (NEUT) ≥ 1.5×109/L, platelet count (PLT) ≥100×109/L, hemoglobin (Hb) ≥90 g/L; ii. Normal renal function or serum creatinine (SCr) ≤ 1.5 times the upper limit of normal value (ULN) or creatinine clearance rate ≥50 ml/min (Cockcroft-Gault formula); iii. Normal liver function or total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal value (ULN); The level of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) is ≤ 2.5 times the upper limit of the normal value (ULN).
• Be able to and willing to abide by the research and follow-up procedures;
• Men and women of gestational age must agree to take adequate contraceptive measures throughout the study period and within 6 months after the end of treatment.
• The patient voluntarily joined this clinical study, signed the informed consent form, had good compliance and was able to cooperate with the follow-up.