Actively Recruiting
Phase II Study Evaluating NALIRIFOX Versus 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
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating two chemotherapy treatments, NALIRIFOX and a modified combination of gemcitabine, nab-paclitaxel, and cisplatin (mGAP), in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) who have not received prior treatment. This Phase 2 trial aims to compare the effectiveness of these regimens in improving clinical outcomes for this serious cancer, which remains a leading cause of cancer-related deaths with a poor prognosis. The study involves two treatment groups: one receiving NALIRIFOX, which includes liposomal irinotecan, oxaliplatin, 5-fluorouracil, and leucovorin administered every two weeks, and the other receiving mGAP, with gemcitabine, nab-paclitaxel, and cisplatin given on Day 1 and Day 15 of a 28-day cycle. The trial investigates whether mGAP can achieve a higher overall response rate with manageable toxicity compared to NALIRIFOX. Participants will undergo regular imaging to assess tumor response and other outcomes such as progression-free and overall survival, duration of response, and treatment safety for up to 30 months. The study requires close monitoring of health status including blood counts and organ function, with continued evaluation of side effects and treatment impact throughout the trial period.
CONDITIONS
Brief 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 informed consent form provided
- Willingness to comply with all study procedures and availability for study duration
- Male or female aged 18 years or older
- For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and during the study plus 9 months after last dose
- Negative pregnancy test at screening for women of childbearing potential
- For males of reproductive potential: use of effective contraception during the study and for 4 months after last dose
- Histologically or cytologically confirmed untreated locally advanced or metastatic pancreatic ductal adenocarcinoma
- Radiographically confirmed measurable disease per RECIST 1.1 and NCCN definition
- Inoperable disease due to locally advanced unresectable tumor or metastases
- ECOG performance status of 0 to 2
- Adequate blood counts: ANC ≥1500/mm3 without growth factors within 7 days before treatment, platelets ≥100,000/mm3
- INR less than 1.5 unless on anticoagulation therapy with therapeutic INR
- Adequate kidney function with creatinine level below 1.6 mg/dL
You will not qualify if you...
- Pregnancy or breastfeeding
- Treatment with another investigational drug or intervention within 30 days before starting the study
- Known allergy or hypersensitivity to any drugs in mGAP or NALIRIFOX
- Any medical or social condition that may interfere with consent, cooperation, participation, or data interpretation
- Unwillingness or inability to comply with study procedures or visits
- Uncontrolled active infection
- Diagnosis other than adenocarcinoma by histology
- Medical conditions preventing major abdominal surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive either NALIRIFOX or modified gemcitabine, nab-paclitaxel, and cisplatin chemotherapy to treat locally advanced or metastatic pancreatic adenocarcinoma.
Visits every 2 weeks for NALIRIFOX or on Day 1 and Day 15 of each 28-day cycle for mGAP
Duration - Up to 30 months
Participants are monitored for treatment response, disease progression, overall survival, and toxicity for up to 30 months after starting treatment.
Periodic visits for assessments as scheduled by the study team
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
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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