A Randomized, Controlled, Phase II Study of Perioperative Camrelizumab Combined With Albumin Paclitaxel and Cisplatin in Patients With Resectable Esophageal Squamous Cell Carcinoma
The purpose of this study is to observe and evaluate the efficacy and safety of camrelizumab combined with albumin paclitaxel and cisplatin as perioperative treatment of advanced esophageal squamous cell.
• Aged 18-80 years, males or females;
• Histologically or cytologically confirmed as ESCC;
• Esophageal squamous cell carcinoma without anti-tumor treatment, and the clinical stage is T1b-2N+M0 or T3-4aN+/-M0 (AJCC/UICC TNM staging system 8th edition);
• It can provide tumor tissue for the detection of PD-L1 expression level;
• Follow-up surgery plan: radical esophageal squamous cell carcinoma surgery with esophagogastric reconstruction combined with at least complete 2 field lymph node dissection;
• ECOG: 0\
‣ 1;
• Expected survival time ≥ 12 weeks;
• Body mass index (BMI) ≥ 18.5kg/m2 or pg-sga score A / B;
• 1)White blood cell count (WBC) ≥3.0 × 109/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet (PLT) count ≥100×109/L, hemoglobin (HGB) ≥90 g/L, No blood transfusion or other hematopoietic factor treatment for the previous 14 days; 2)Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); serum total bilirubin (TBIL) ≤1.5×ULN ; Albumin (ALB) ≥30g/L; 3)Serum creatinine (CRE)≤1.0×ULN, creatinine clearance (Ccr)≥60 mL/min (Cockcroft-Gault formula); 4)International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) ≤ 1.5 × ULN;
⁃ Important organ functions: a) Heart function: normal or grade I; b) Lung function: FEV1\>1.2L, FEV1% \>40%; c) Liver function: Child-Pugh grade 5-6 points;
⁃ For premenopausal women (postmenopausal women must have been postmenopausal for at least 12 months to be considered infertile), the serum pregnancy test result is negative. Male subjects (including male subjects' female spouses of childbearing age) and female subjects of childbearing age must contraception from the first study drug administration to 6 months after the last study drug administration;
⁃ Obtain the informed consent signed by the subject or his legal representative;
⁃ Can cooperate to complete research procedures and follow-up inspections。