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

Recruiting now · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT06389760

Run by

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

People needed

57

Starts

2023-10-18

Expected to finish

2026-09-30

Last updated by the study team

2024-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.