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RECRUITING
NCT07163273
PHASE2

Monthly Alternating NALIRIFOX and GnP in the First-Line Setting for Metastatic Pancreatic Ductal Adenocarcinoma

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

A prospective, interventional, single-center, single-arm, open-label, phase II study for patients with metastatic pancreatic cancer. The intervention consists of monthly alternating standard chemotherapy regimens-NALIRIFOX and GnP. The hypothesis is that induction therapy with alternating NALIRIFOX and GnP has better efficacy compared to historical observation.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

41

Start Date

2025-06-20

Completion Date

2027-06-20

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

NALIRIFOX

NALIRIFOX consists of 5-FU 2400 mg/m2 over 46 hours, liposomal irinotecan 50 mg/m2, and oxaliplatin 60 mg/m2, which would be given on Day 1 and Day 15

DRUG

Gemcitabine plus nab-Paclitaxel (GnP)

GnP consists of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2, given on Days 1, 8, and 15.

Locations (7)

Imbert Cancer Center

Bay Shore, New York, United States

Northern Westchester Cancer Center

Mount Kisco, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Zuckerberg Cancer Center

New Hyde Park, New York, United States

Manhattan Eye, Ear and Throat Hospital

New York, New York, United States

NHPP Medical Oncology at Rego Park

Rego Park, New York, United States

Phelps Cancer Center

Sleepy Hollow, New York, United States