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

NCT06389760 | Recruiting Phase 2

• 1 other identifier: IST-Nim-PC-16
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer

Keywords

Nimotuzumab; mFOLFIRINOX; adjuvant therapy; pancreatic cancer; GX

Outcome Measures

Primary Outcomes (1)

• disease-free survival (DFS)

  The time from the date of surgery to the disease recurrence or death, whichever is earlier.

  Up to 24 months

Secondary Outcomes (2)

• overall survival (OS)

  Up to 24 months

• adverse events

  Up to 30 days after last administration

Study Arms (1)

Nimotuzumab+ mFOLFIRINOX/GX

EXPERIMENTAL

Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.

Drug: Nimotuzumab; Drug: mFOLFIRINOX; Drug: GX

Interventions

Nimotuzumab DRUG

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).

Also known as: Taixinsheng

Nimotuzumab+ mFOLFIRINOX/GX

mFOLFIRINOX DRUG

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).

Nimotuzumab+ mFOLFIRINOX/GX

GX DRUG

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).

Nimotuzumab+ mFOLFIRINOX/GX

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Juan Du, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Juan Du, MD

CONTACT

86-25-83106666; dujuanglyy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 29, 2024
• Study Start: October 18, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)