Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer

Official title

Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study

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.

Detailed 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.

Interventions

• Drug 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).
• Drug 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).
• Drug 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).

Primary outcome measures

• disease-free survival (DFS) [Time frame: Up to 24 months]

Secondary outcome measures (2)

• overall survival (OS) [Time frame: Up to 24 months]
• adverse events [Time frame: Up to 30 days after last administration]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing

Identifiers

NCT: NCT06389760 · IST-Nim-PC-16

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗