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

Phase 2

Recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: Nimotuzumab; Drug: mFOLFIRINOX; Drug: GX

• Registration Number: NCT06389760
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2023-10-18
• Study First Submitted: 2024-04-11
• Study First Submitted QC: 2024-04-24
• Study First Posted: 2024-04-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-31
• Primary Completion: 2026-09-30
• Study Completion: 2026-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 57

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nimotuzumab+ mFOLFIRINOX/GX	Nimotuzumab	Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.
Nimotuzumab+ mFOLFIRINOX/GX	mFOLFIRINOX	Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.
Nimotuzumab+ mFOLFIRINOX/GX	GX	Patients will receive chemotherapy (either mFOLFIRINOX or GX) plus Nimotuzumab as postoperative adjuvant therapy.

Primary Outcome Measures

Name	Time	Method
disease-free survival (DFS)	Up to 24 months	The time from the date of surgery to the disease recurrence or death, whichever is earlier.

Secondary Outcome Measures

Name	Time	Method
overall survival (OS)	Up to 24 months	The time from the date of surgery to death due to any cause.
adverse events	Up to 30 days after last administration	Frequency and severity of adverse events.

Trial Locations

Locations (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China