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

Nanjing University

Status and phase

Enrolling

Phase 2

Conditions

Pancreatic Cancer

Treatments

Drug: GX

Drug: Nimotuzumab

Drug: mFOLFIRINOX

Study type

Interventional

Funder types

Other

Identifiers

NCT06389760

IST-Nim-PC-16

Details and patient eligibility

About

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.

Full 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.

Enrollment

57 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Age 18 years or older, gender unlimited;
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
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;
1. No prior tumor therapy;
1. 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;
1. Left ventricular ejection fraction (LVEF) ≥ 50%;
1. Fertile subjects are willing to take contraceptive measures during the study period.
1. good compliance and signed informed consent voluntarily

Exclusion criteria

1. Prior systemic anti-tumor therapy, such as chemotherapy, radiotherapy;
1. Participated in other drug clinical trials within 4 weeks;
1. History of other malignancies;
1. Immunodeficiency, or other immune-related disorders requiring medical intervention;
1. Postoperative complications such as bleeding;
1. Woman who are pregnant or breastfeeding;
1. 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.