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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

2025-11-07

Completion Date

2029-11

Last Updated

2025-11-12

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 (1)

Medical University of South Carolina Hollings Cancer Center

Charleston, South Carolina, United States