RecruitingPhase 2NCT06389760

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

57 participants

Start Date

Oct 18, 2023

Study Type

INTERVENTIONAL

Conditions

Pancreatic Cancer

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding nimotuzumab (an antibody that blocks a growth signal called EGFR) to standard post-surgery chemotherapy (mFOLFIRINOX or the GX regimen) improves outcomes for people who have had their pancreatic cancer surgically removed. **You may be eligible if...** - You are 18 or older and have had complete surgical removal of pancreatic cancer (R0 or R1 resection) with no signs of spread - You have not received any prior cancer treatment - Your general health is good (ECOG 0 or 1) - Your heart, liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You have previously received chemotherapy or radiation for this cancer - You have participated in another drug trial within the last 4 weeks - You have had a prior cancer diagnosis - You have an immune deficiency or postoperative complications like bleeding - You are pregnant or breastfeeding - You are allergic to any of the study drugs (nimotuzumab, oxaliplatin, irinotecan, fluorouracil, gemcitabine, or capecitabine) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNimotuzumab

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).

DRUGmFOLFIRINOX

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).

DRUGGX

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).