Overview
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.
Description
This clinical study is designed as a prospective, multicenter, single arm, open-label study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX/GX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included overall survival (OS) and safety.
Eligibility
Inclusion Criteria:
- 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
Exclusion Criteria:
- 1\. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
- 2\. Participated in other drug clinical trials within 4 weeks;
- 3\. History of other malignancies;
- 4\. Immunodeficiency, or other immune-related disorders requiring medical intervention;
- 5\. Postoperative complications such as bleeding;
- 6\. Woman who are pregnant or breastfeeding;
- 7\. Drug abuse, or clinical, psychological or social factors that may have an impact on informed consent or the implementation of the study;
- 8.Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.
