What this study is
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.
What's being tested
- Biospecimen Collection
Intervention · PROCEDURE
Undergo blood sample collection
- Computed Tomography
Intervention · PROCEDURE
Undergo CT
- Fluorouracil
Intervention · DRUG
- Irinotecan Sucrosofate
Intervention · DRUG
- Leucovorin Calcium
Intervention · DRUG
- Oxaliplatin
Intervention · DRUG
- Surgical Procedure
Intervention · PROCEDURE
Undergo surgical resection
All of Fluorouracil, Irinotecan Sucrosofate, Leucovorin Calcium, Oxaliplatin
Given IV
Study details
- Official title
- A Phase 2 Clinical Trial of Nalirifox as Neoadjuvant Treatment for Patients With Borderline Resectable Pancreatic Ductal Adenocarcinoma (Nectar Study)
- Sponsor
- Roswell Park Cancer Institute
- Conditions
- Borderline Resectable Pancreatic Ductal Adenocarcinoma
- Enrolling
- 20 people
- Starts
- 2026-03-02
- Est. completion
- 2027-03-01
- Design
- Open-label, single group, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age ≥ 18 old
- Have histologically or cytologically confirmed pancreatic ductal adenocarcinoma (PDAC) that is borderline resectable (BR) using the National Comprehensive Cancer Network criteria
- Have a documented Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
- Absolute neutrophil count (ANC) ≥ 1,500 cells/uL without the use of hematopoietic growth factors
- Platelet count ≥ 100,000 cells/uL
- Hemoglobin ≥ 9 g/dL
- Plasma total bilirubin ≤ upper limit of normal (ULN) (biliary drainage is allowed for biliary obstruction)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatine clearance of > 30 mL/min (per Cockroft-Gault equation)
- Plasma albumin ≥ 3 g/dL
- Have measurable or evaluable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form (ICF) prior to receiving any study related procedure
You can't join if
- Patients who have had previous chemotherapy or radiotherapy for PDAC
- Patients with resectable, unresectable, or metastatic PDAC
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openRoswell Park Cancer Institute
Buffalo, New York, United States
- Ask RPCI · Contact877-275-7724askrpci@roswellpark.org
- Christos Fountzilas · Principal investigator
Recruiting
Study team
Sponsor
Roswell Park Cancer Institute
Study ID I-4064824
Principal investigator
Christos Fountzilas
Roswell Park Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.