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Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06389760•The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Key Dates

Start Date

October 18, 2023

Primary Completion Date

September 30, 2026

Completion Date

September 30, 2026

Last Updated

October 31, 2024

Enrollment

ESTIMATED participants

Conditions

Pancreatic Cancer

Interventions

Nimotuzumab

DRUG

mFOLFIRINOX

DRUG

Contacts

Juan Du, MD

CONTACT

86-25-83106666 dujuanglyy@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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