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RECRUITING
NCT07076212
PHASE2

Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

Summary

This is a single-center, open-label, randomized Phase 2 trial to evaluate the efficacy of NALIRIFOX (Arm 1) vs mGAP (Arm 2) in previously untreated patients with locally advanced (unresectable) and metastatic pancreatic ductal adenocarcinoma (PDAC).

Official title: Phase II Study Evaluating NALIRIFOX Versus Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-04-02

Completion Date

2029-11

Last Updated

2026-05-06

Healthy Volunteers

No

Interventions

DRUG

Liposomal Irinotecan

50 mg/m2 will be administered on Day 1 of a 2-week cycle

DRUG

Oxaliplatin

60 mg/m2 will be administered on Day 1 of a 2-week cycle

DRUG

5-Fluorouracil

5-fluorouracil (2400 mg/m2 over 46 hours) will begin administration on Day 1 of a 2-week cycle

DRUG

Leucovorin

400 mg/m2 will be administered on Day 1 of a 2-week cycle

DRUG

Gemcitabine (mg/m²)

1000 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

DRUG

Nab-paclitaxel

125 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

DRUG

Cisplatin

25 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle

Locations (2)

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, United States

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States