Actively Recruiting
Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
Led by Medical University of South Carolina · Updated on 2026-05-06
52
Participants Needed
2
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form provided
- Willingness to comply with all study procedures and availability for the study duration
- Male or female aged 18 years or older
- Females of reproductive potential must use highly effective contraception for at least 1 month before screening, during the study, and for 9 months after last dose
- Female participants must have a negative pregnancy test at screening
- Males of reproductive potential must use effective contraception during the study and for 4 months after last dose
- Histologically or cytologically confirmed locally advanced or metastatic pancreatic ductal adenocarcinoma not previously treated
- Radiographically confirmed measurable disease per RECIST 1.1 and NCCN definition
- Inoperable due to locally advanced unresectable disease or metastases
- Eastern Cooperative Oncology Group performance status 0 to 2
- Hematological and organ function criteria including ANC ≥1500/mm3, platelet count ≥100,000/mm3, INR <1.5 (or therapeutic if on anticoagulation), and serum/plasma creatinine <1.6 mg/dL
You will not qualify if you...
- Pregnancy or lactation
- Treatment with another investigational drug or intervention within 30 days before starting the study
- Known allergy or hypersensitivity to any components of mGAP or NALIRIFOX
- Any medical or social condition that may interfere with consent, cooperation, participation, or result interpretation
- Unwillingness or inability to comply with study procedures or visits
- Uncontrolled active infection
- Histologic diagnosis other than adenocarcinoma
- Medical conditions that prevent major abdominal surgery
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
2
Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
H
HCC Clinical Trials Office, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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