New chemo cocktail aims to boost pancreatic cancer surgery success
NCT ID NCT06821997
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial is testing a chemotherapy combination called NALIRIFOX given before surgery to people with borderline resectable pancreatic cancer. The goal is to shrink the tumor enough to allow successful removal and reduce the chance of the cancer coming back. The study will enroll 20 participants and measure how many have a major response in the tumor tissue after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NALIRIFOX (liposomal irinotecan, oxaliplatin, 5-fluorouracil, leucovorin)
- What this could lead to
- If successful, this approach could make surgery more effective and lower the chance of cancer returning in patients with borderline resectable pancreatic cancer.
- What could go wrong
- This is a small, early-phase trial with only 20 participants. The chemotherapy combination may cause significant side effects, and it is not yet known if it will improve long-term outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Other studies related to the condition(s) this trial covers.
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