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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
2025-11-07
Completion Date
2029-11
Last Updated
2025-11-12
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 (1)
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States