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NALIRIFOX Before Surgery for Borderline Resectable Pancreatic Cancer

This study is testing a treatment called NALIRIFOX (liposomal irinotecan, oxaliplatin, 5-fluorouracil, and leucovorin) before surgery for pancreatic cancer that is borderline resectable. This means the cancer is close to major blood vessels but might still be removable by surgery. Liposomal irinotecan is a form of the drug irinotecan that is contained in tiny, fat-like particles, which may have fewer side effects and work better. The study aims to see how well NALIRIFOX shrinks the tumor before surgery. You may be able to join if you are at least 18 years old and have this type of pancreatic cancer. The study is looking for a major pathologic response (how much cancer cells are killed) up to 5 years after treatment. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 20 participants. It is testing a specific treatment regimen.
What's involved
You would receive NALIRIFOX intravenously every 14 days for 4-8 cycles, followed by surgery 4-8 weeks later. After surgery, you might receive up to 4 additional cycles of NALIRIFOX. You would also have blood samples collected and undergo CT scans.
Compensation
Not stated in the trial record.
Follow-up
The study measures major pathologic response up to 5 years after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06821997

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Roswell Park Cancer Institute
~20 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyFluorouracilIrinotecan SucrosofateLeucovorin CalciumOxaliplatin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Major pathologic response (MPR)
Measured over Up to 5 years

Conditions

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Explore related trials

Pancreatic Ductal Adenocarcinoma

NCT06821997

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Roswell Park Cancer Institute

    Buffalo, New Yorkstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Christos Fountzilas · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Ask RPCI
[email protected]
877-275-7724
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years of age
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

Exclusion

Patients who have had previous chemotherapy or radiotherapy for PDAC
Patients with resectable, unresectable, or metastatic PDAC
Presence of germline glucuronosyltransferase (UGT) 1A1 (\*28 or \*6) or dihydropyrimidine dehydrogenase (DPD) polymorphisms (DPYD\*2A \[rs3918290, c.1905+1G\>A, IVS14+1G\>A\], c.2846A\>T \[rs67376798, D949V\], c.1679T\>G \[rs55886062, DPYD\*13, I560S\], and c.1236G\>A \[rs56038477, E412E, in haplotype B3\]) known to significantly impact CPT-11 and fluorouracil metabolism and associated with increased risk for toxicities
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

What this trial measures

  • Major pathologic response (MPR)Up to 5 years

    MPR will be defined as either complete pathologic response or minimal residual cancer based on the American College of Pathology system. The MPR status will be summarized using frequencies and relative frequencies.