Overview
This is a prospective, multicenter, single-arm, phase II trial. The main purpose of the study is to evaluate the efficacy and safety of Nimotuzumab combined with mFOLFIRINOX for postoperative adjuvant treatment of pancreatic cancer.
Description
This clinical study is designed as a prospective, multicenter, open-label, single arm, phase II study to evaluate the clinical efficacy and safety of combination Nimotuzumab with mFOLFIRINOX as postoperative adjuvant therapy in pancreatic cancer. The main endpoint is disease-free survival (DFS). Additional end points included distant metastasis-free survival (DMFS), overall survival (OS), quality of life, tumor-related markers and safety.
Eligibility
Inclusion Criteria:
- 1. Age 18-70 years old, gender unlimited;
- 2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) with no evidence of distant metastasis as demonstrated by imaging;
- 3. Postoperative pathology suggested R0/R1 resection;
- 4. Receive nimotuzumab and mFOLFIRINOX for voluntary;
- 5. Measurable disease according to RECIST criteria v1.1;
- 6. Adequate organ and bone marrow function, defined as follows: hemoglobin≥9.0 g/dL; absolute neutrophil count (ANC)≥1.5×10^9/L; platelets≥100×10^9/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≤1.5×ULN or estimated creatinine clearance > 60 mL/min;
- 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- 8. Postoperative survival was expected to be ≥3 months;
- 9. Fertile subjects are willing to take contraceptive measures during the study period.
- 10. good compliance and signed informed consent voluntarily
Exclusion Criteria:
- 1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma;
- 2. History of other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- 3. Accompanied by other serious diseases, including but not limited to: compensatory heart failure (NYHA grade III and IV), unstable angina, poorly controlled arrhythmias, uncontrolled hypertension; active infections; unmanageable diabetes mellitus; presence of uncontrolled pleural effusion, pericardial effusion, or ascites requiring drainage; severe portal hypertension; gastric outlet obstruction; Respiratory insufficiency;
- 4. Postoperative complications such as bleeding, pancreatic fistula, gastric obstruction, abdominal infection, and biliary fistula, which made the patient unable to receive adjuvant therapy within 12 weeks after surgery;
- 5. CA199>180 U/ml within 21d before adjuvant therapy;
- 6. Known allergy to prescription or any component of the prescription used in this study;
- 7. With HIV, HPV, or syphilis infection, or active hepatitis (hepatitis B, hepatitis C)
- 8.Other reasons that are not suitable to participate in this study according to the researcher's judgment.