Pre-surgery NALIRIFOX for borderline resectable pancreatic ductal adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-arm phase II trial gives NALIRIFOX (liposomal irinotecan, oxaliplatin, infusional 5‑fluorouracil, and leucovorin) every 14 days for 4–8 cycles as neoadjuvant therapy to patients with borderline resectable pancreatic ductal adenocarcinoma. Patients undergo surgical resection 4–8 weeks after the last preoperative dose and may receive up to 4 additional cycles of the same regimen starting 4–12 weeks after surgery. Primary endpoints focus on antitumor efficacy, with secondary endpoints examining clinical efficacy, tolerability, and safety, and exploratory objectives include blood- and tumor-based biomarker studies. CT imaging and serial blood/tissue biospecimen collection are used throughout the study to monitor response, resectability, and correlate biomarkers with outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Roswell Park Cancer Institute
  Buffalo, New York, United States Recruiting

Study contacts

• Principal investigator: Christos Fountzilas — Roswell Park Cancer Institute

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.