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Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
Sponsor: Medical University of South Carolina
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
Liposomal Irinotecan
50 mg/m2 will be administered on Day 1 of a 2-week cycle
Oxaliplatin
60 mg/m2 will be administered on Day 1 of a 2-week cycle
5-Fluorouracil
5-fluorouracil (2400 mg/m2 over 46 hours) will begin administration on Day 1 of a 2-week cycle
Leucovorin
400 mg/m2 will be administered on Day 1 of a 2-week cycle
Gemcitabine (mg/m²)
1000 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
Nab-paclitaxel
125 mg/m2 will be administered on Day 1 and Day 15 of a 4-week cycle
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