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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment20 people
  • Recruiting US sites1
  • SponsorRoswell Park Cancer Institute
  • RegistryNCT06821997

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial: a one-minute explainerNCT068219971 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join 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 cannot 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Biospecimen Collection (Procedure): Undergo blood sample collection
  • Computed Tomography (Procedure): Undergo CT
  • Fluorouracil (Drug): Given IV
  • Irinotecan Sucrosofate (Drug): Given IV
  • Leucovorin Calcium (Drug): Given IV
  • Oxaliplatin (Drug): Given IV
  • Surgical Procedure (Procedure): Undergo surgical resection

The study

Treatment groups

Na · Single Group · masking: None

Treatment (NALIRIFOX) (Experimental)

Patients receive liposomal irinotecan IV over 90 minutes, oxaliplatin IV over 120 minutes, leucovorin IV over 30 minutes and fluorouracil IV over 48 hours on day 1 of each cycle. Cycles repeat every 14 days for 4-8 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo surgical resection 4-8 weeks after the last treatment dose. Starting 4-12 weeks after surgery, patients receive liposomal irinotecan, oxaliplatin, leucovorin, and fluorouracil for up to 4 additional cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT and blood sample collection throughout the study.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • blood samples: Part of the study plan
  • CT scans: Part of the study plan
  • surgery: Part of the study plan

Goals

What the study measures

Main goals

  • Major pathologic response (MPR) (Up to 5 years)

Other goals

  • Objective response rate (ORR)
  • CA19-9 response rate
  • Carcinoembryonic antigen response rate
  • Positive margin resection rate
  • Disease-free survival
  • Overall survival
  • Incidence of adverse events

Planned enrollment: 20 (estimated).

Where

Recruiting US sites

  • Roswell Park Cancer Institute, Buffalo, New York

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 20, 2026. Public record; not medical advice.

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