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

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

NCT ID: NCT06389760

Condition: Pancreatic Cancer

Conditions: Official terms:
Pancreatic Neoplasms
Nimotuzumab

Conditions: Keywords:
Nimotuzumab
mFOLFIRINOX
adjuvant therapy
pancreatic cancer
GX

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Nimotuzumab
Description: 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).
Arm group label: Nimotuzumab+ mFOLFIRINOX/GX

Other name: Taixinsheng

Intervention type: Drug
Intervention name: mFOLFIRINOX
Description: 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).
Arm group label: Nimotuzumab+ mFOLFIRINOX/GX

Intervention type: Drug
Intervention name: GX
Description: 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).
Arm group label: Nimotuzumab+ mFOLFIRINOX/GX

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.

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.

Criteria for 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Address:
City: Nanjing
Zip: 210008
Country: China

Status: Recruiting

Contact:
Last name: Juan Du, M.D. Ph.D

Phone: +86-025-83106666
Email: dujunglyy@163.com

Investigator:
Last name: Juan Du, M.D. Ph.D
Email: Principal Investigator

Start date: October 18, 2023

Completion date: September 30, 2026

Lead sponsor:
Agency: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class: Other

Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06389760