Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study
This is a prospective, multicenter, single-arm, open-label study. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX/GX for postoperative adjuvant treatment of pancreatic cancer.
• 1\. Age 18 years or older, gender unlimited;
• 2\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• 3\. Had undergone complete macroscopic resection for pancreatic cancer (R0 or R1 resection) with histological confirmation and with no evidence of distant metastasis as demonstrated by imaging;
• 4\. No prior tumor therapy;
• 5\. Adequate organ and bone marrow function, defined as follows: White blood cells (WBC) ≥ 3.0×10\^9/L; absolute neutrophil count (ANC)≥1.5×10\^9/L; hemoglobin≥9.0 g/dL; platelets≥75×10\^9/L; serum total bilirubin (TBIL)≤1.5×ULN; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times the upper limit of normal (ULN); serum creatinine≤1×ULN or estimated creatinine clearance ≥ 50 mL/min;
• 6\. Left ventricular ejection fraction (LVEF) ≥ 50%;
• 7\. Fertile subjects are willing to take contraceptive measures during the study period.
• 8\. good compliance and signed informed consent voluntarily