Efficacy and Safety of Neoadjuvant Pembrolizumab in III-IVA Resectable Oral Squamous Cell Carcinoma
The purpose of this prospective, single-center, single-arm, open-label II phase observation clinical trial is to evaluate the efficacy and safety of Pembrolizumab immunoadjuvant therapy in patients with stage III-IVA oral squamous cell carcinoma. The primary end point is the pathological tumor remission rate of the primary tumor and regional lymph nodes after neoadjuvant immunotherapy (pTR-2: the proportion of necrotic tumor cells, keratin fragments and giant cells in tissue sections \> 50%). The secondary endpoints are 1-year disease-free survival (DFS), 1-year overall survival (OS) and the incidence of adverse events, compared with historical data. In addition, we will check the relevant immune indicators, such as PD-L1 and CPS scores.
• Age 18-70
• Male and female
• Patients histologically or cytologically difined as oral cavity squamous cell carcinoma
• According to the American Joint Committee on Cancer ( AJCC 8th Edition ) , patients with resectable stage III-IVA OCSCC
• ECOG performance status ≤ 1
• Patients with normal bone marrow and organ function as defined below:
∙ Blood routine examination:
⁃ Absolute neutrophil count ≥ 1.5×109/L;
⁃ Platelets ≥ 100.0×109/L;
⁃ Hemoglobin ≥ 9.0 g/dL.
∙ Liver function:
⁃ Totle bilirubin ≤ 2.0×ULN(Upper Limit Of Normal);
⁃ Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase
‣ 2.5×ULN;
⁃ Albumin ≥ 2.8g/dL.
∙ Renal function:
∙ (1)Creatinine clearance rate \> 60.0ml/min.
∙ Coagulation function:
∙ (1)International Normalized Ratio ≤ 1.5；Activated Partial Thromboplastin Time ≤ 1.5×ULN
• Prior to and during study, and lasting 120 days for the final utilization of pembrolizumab, patients approve of contraception
• Patients voluntarily agree to participate in the study and sign the informed consent form