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NCT06821997 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Borderline Resectable Pancreatic Ductal Adenocarcinoma, sponsored by Roswell Park Cancer Institute.

Recruiting
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT06821997: Recruiting Phase 2 study of Borderline Resectable Pancreatic Ductal Adenocarcinoma, sponsored by Roswell Park Cancer Institute.

NCT06821997 is a Phase 2 study of Borderline Resectable Pancreatic Ductal Adenocarcinoma that is actively recruiting participants, run by Roswell Park Cancer Institute. The registered enrollment target is 20 participants, below the 71-participant average among 3 other Borderline Resectable Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06821997, a Phase 2 study of Borderline Resectable Pancreatic Ductal Adenocarcinoma, is actively recruiting participants, sponsored by Roswell Park Cancer Institute.

RECRUITING
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

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.

Primary Outcome

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.

Conditions Studied

Borderline Resectable Pancreatic Ductal Adenocarcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Fluorouracil
  • DRUG Leucovorin Calcium
  • DRUG Irinotecan Sucrosofate

Study Locations (1)

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2026-02-01
Est. Completion 2027-03-01
Phase Phase 2
Roswell Park Cancer Institute

365 total trials

What NCT06821997 shows while recruiting

NCT06821997 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 71-participant average among 3 other Borderline Resectable Pancreatic Ductal Adenocarcinoma trials with a reported enrollment target (72% lower).

The record links to 1 condition, with Borderline Resectable Pancreatic Ductal Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06821997 reports a single indexed study location in New York.

Frequently Asked Questions

What is clinical trial NCT06821997 about?

NCT06821997 is a clinical study titled "NALIRIFOX Before Surgery for the Treatment of Borderline Resectable Pancreatic Ductal Adenocarcinoma, Nectar Trial". 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)....

What is the current status of trial NCT06821997?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2026-02-01. Estimated completion is 2027-03-01.

What conditions does trial NCT06821997 study?

This clinical trial studies the following conditions: Borderline Resectable Pancreatic Ductal Adenocarcinoma.

What interventions are being tested in trial NCT06821997?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Fluorouracil (DRUG), Leucovorin Calcium (DRUG), Irinotecan Sucrosofate (DRUG).

Who is sponsoring clinical trial NCT06821997?

This trial is sponsored by Roswell Park Cancer Institute, which has 365 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06821997 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06821997

Source: ClinicalTrials.gov NCT06821997, the US trial registry maintained by the National Library of Medicine. NCT06821997 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.