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

PHASE2RecruitingINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

October 18, 2023

Primary Completion Date

September 30, 2026

Study Completion Date

September 30, 2026

Conditions
Pancreatic Cancer
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).

Trial Locations (1)

210008

RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Nanjing

All Listed Sponsors
lead

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER