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NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Eligibility criteria shortened, about 30 words
    • Secondary endpoints: details revised at 5 of 7 entries
  2. Minor Start date changed from estimate of Feb 1, 2026 to Mar 2, 2026v7
  3. Notable Start date: Dec 1, 2025 to Feb 1, 2026v6
  4. Notable Start date: Oct 1, 2025 to Dec 1, 2025v5
  5. Notable Start date: Aug 1, 2025 to Oct 1, 2025v4
Show 2 earlier versionsHide 2 earlier versions
  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 1, 2025 to Aug 1, 2025
    • Site details revised
    v3
  2. Notable Start date: Mar 1, 2025 to Jun 1, 2025
    • Site contact updated
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase II trial tests how well liposomal irinotecan, oxaliplatin, 5-fluorouracil and leucovorin (NALIRIFOX) before surgery works in treating patients with pancreatic ductal adenocarcinoma that is close to major blood vessels, but is still potentially removable by surgery (borderline resectable). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Liposomal irinotecan is a form of the anticancer drug irinotecan that is contained inside very tiny, fat-like particles. Liposomal irinotecan may have fewer side effects and work better than other forms of the drug. Oxaliplatin is in a class of medications called platinum-containing antineoplastic agents. It damages the cell's DNA and may kill tumor cells. 5-fluorouracil, a type of antimetabolite, stops cells from making DNA and it may kill tumor cells. Leucovorin, a form of folic acid, is used to lessen the toxic effects of substances that block the action of folic acid. It is a type of chemoprotective agent and a type of chemosensitizing agent. Giving NALIRIFOX before surgery may improve the chance of successful surgery and decrease the chance of the cancer returning after surgery in patients with borderline resectable pancreatic ductal adenocarcinoma.
Trial Details
NCT Number NCT06821997
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)
Borderline Resectable Pancreatic Ductal Adenocarcinoma
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov