Nimotuzumab with mFOLFIRINOX/GX for pancreatic cancer treatment after surgery

Nimotuzumab Combined With mFOLFIRINOX/GX as Postoperative Adjuvant Therapy in Pancreatic Cancer: a Prospective, Multicenter, Single-arm, Open-label Study

This study is testing if adding Nimotuzumab to a standard chemotherapy treatment helps people with pancreatic cancer stay cancer-free after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Drugs / interventions: nimotuzumab, chemotherapy
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06389760 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness and safety of combining Nimotuzumab with mFOLFIRINOX/GX as postoperative adjuvant therapy for patients with pancreatic cancer. It is a prospective, multicenter, single-arm, open-label study focusing on disease-free survival as the primary endpoint, while also assessing overall survival and safety. Participants will receive this combination treatment after undergoing complete surgical resection of their tumors.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have undergone complete surgical resection for pancreatic cancer and have no evidence of distant metastasis.

Not a fit: Patients with prior tumor therapy or those with significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free survival rates for patients with pancreatic cancer after surgery.

How similar studies have performed: Other studies have shown promising results with similar combination therapies in treating pancreatic cancer, indicating potential for success.

Eligibility criteria

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.

Where this trial is running

Nanjing, Jiangsu

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

Study contacts

• Study coordinator: Juan Du, MD

Conditions Pancreatic Cancer; Nimotuzumab; mFOLFIRINOX; adjuvant therapy; pancreatic cancer; GX