Nimotuzumab Combined with Nab-paclitaxel+ Gemcitabine As Postoperative Adjuvant Therapy in Patients with EGFR-positive Pancreatic Cancer: a Prospective, Single-arm Study
This is a prospective, single-arm trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with nab-paclitaxel+ gemcitabine (AG regimen) for postoperative adjuvant treatment of pancreatic cancer with EGFR-positive.
• 1\. Able and willing to provide a written informed consent.
• 2\. Age 18-75 years old, gender unlimited;
• 3\. Histologically or cytologically confirmed resected pancreatic ductal adenocarcinoma (PDAC), resectable evaluation is based on criteria of NCCN guidelines, no evidence of distant metastasis as demonstrated by imaging;
• 4\. Postoperative pathology suggested R0/R1 resection;
• 5\. EGFR positive (by immunohistochemistry);
• 6\. KRAS gene and CDX-2 protein status must have been determined at baseline (only for post hoc analysis);
• 7\. Adequate organ and bone marrow function, defined as follows: absolute neutrophil count (ANC)≥1.5×10\^9/L; platelets≥80×10\^9/L; hemoglobin≥9.0 g/dL; 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≤1.5×ULN or estimated creatinine clearance \> 60 mL/min;
• 8\. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• 9\. Postoperative survival is expected to be ≥3 months;
• 10\. Fertile subjects are willing to take contraceptive measures during the study period.