Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer
Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
57 participants
Oct 18, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- \. Age 18 years or older, gender unlimited;
- \. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- \. 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;
- \. No prior tumor therapy;
- \. 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;
- \. Left ventricular ejection fraction (LVEF) ≥ 50%;
- \. Fertile subjects are willing to take contraceptive measures during the study period.
- \. good compliance and signed informed consent voluntarily
Exclusion Criteria8
- \. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
- \. Participated in other drug clinical trials within 4 weeks;
- \. History of other malignancies;
- \. Immunodeficiency, or other immune-related disorders requiring medical intervention;
- \. Postoperative complications such as bleeding;
- \. Woman who are pregnant or breastfeeding;
- \. Drug abuse, or clinical, psychological or social factors that may have an impact on informed consent or the implementation of the study;
- Known allergy to prescription or any component of the prescription used in this study, including nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, and capecitabine.
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Interventions
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).
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).
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).
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06389760