Pancreatic Cancer Research

Clinical trialPhase 2Enrolling by invitation

A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer

A Prospective, Single-Arm Study of Nimotuzumab Combined With NALIRIFOX Regimen as First-Line Treatment for Locally Advanced or Metastatic Pancreatic Cancer

Outcome
Ongoing
Phase
Phase 2
Status
Enrolling by invitation
Study type
Interventional
Start
6 June 2026
Expected end
10 August 2028
Enrollment
45 participants
Sites
1
Primary outcomes
Progression-free survival (PFS)
Sponsor
Other
Results posted
No
Last update
6 November 2026

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Brief summary public domain (ClinicalTrials.gov)

This is a prospective, single-arm study in patients with locally advanced or metastatic pancreatic cancer that cannot be treated with surgery. The study is planned to enroll 42 patients. All patients will receive nimotuzumab combined with the NALIRIFOX chemotherapy regimen as first-line treatment. Nimotuzumab is a targeted antibody against EGFR. NALIRIFOX is a standard first-line chemotherapy regimen for advanced pancreatic cancer and includes liposomal irinotecan, oxaliplatin, leucovorin, and 5-FU. Nimotuzumab 400 mg will be given intravenously on Day 1 every 2 weeks. The NALIRIFOX regimen will also be given every 2 weeks. Treatment will continue until the cancer grows or the side effects become unacceptable. The main purpose of this study is to find out how long patients live without their cancer getting worse (progression-free survival, PFS). The study will also look at overall survival, tumor response rate, disease control rate, time to progression, and safety, especially serious side effects. Patients will be followed closely during treatment. Imaging tests will be done every 8 weeks to check the cancer. After treatment ends, patients will be followed for survival for up to 24 months after the last patient is enrolled.