Nimotuzumab: When combined with the mFOLFIRINOX regimen, nimotuzumab (nimo) will be administered at a dose of 400mg on Day 1 and 15 of a 28-day cycle (6 cycles). When combined with the GX regimen, nimotuzumab will be given at 400mg on Day 1 and 8 of a 21-day cycle (8 cycles).
mFOLFIRINOX: Patients will receive mFOLFIRINOX as follows: Oxaliplatin 65 mg/m2 on Day 1 and 15 of a 28-day cycle; Irinotecan 130 mg/m2 on Day 1 and 15 of a 28-day cycle; Leucovorin(LV) 200 mg/m2 Day 1 and 15 of a 28-day cycle; 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day 1 and 15 of a 28-day cycle (6 cycles).
GX: Patients will receive GX regimen as follows: Gemcitabine 1000 mg/m2 on Day 1 and 8 of a 21-day cycle; capecitabine 2000 mg/m2 on d1-14 a 21-day cycle(8 cycles).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
disease-free survival (DFS) — Up to 24 months The time from the date of surgery to the disease recurrence or death, whichever is earlier.
Trial sites (1)
Facility
City
Region
Status
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing
Jiangsu
Recruiting
More The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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