Actively Recruiting
NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial
Led by Roswell Park Cancer Institute · Updated on 2026-04-01
20
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically or cytologically confirmed borderline resectable pancreatic ductal adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count of at least 1,500 cells/uL without growth factors
- Platelet count of at least 100,000 cells/uL
- Hemoglobin level of at least 9 g/dL
- Plasma total bilirubin within normal limits (biliary drainage allowed if needed)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) no more than 2.5 times the upper normal limit
- Creatinine clearance above 30 mL/min
- Plasma albumin level of at least 3 g/dL
- Measurable or evaluable disease according to RECIST 1.1 criteria
- Women of childbearing potential agree to use effective contraception
- Ability to understand and sign informed consent form
You will not qualify if you...
- Prior chemotherapy or radiotherapy for pancreatic ductal adenocarcinoma
- Pancreatic ductal adenocarcinoma that is resectable, unresectable, or metastatic
- Presence of certain genetic polymorphisms impacting irinotecan and fluorouracil metabolism
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social issues affecting compliance
- Pregnant or nursing females
- Inability or unwillingness to follow study protocol
- Any condition making the participant unsuitable for study drug as determined by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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