Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
Recruiting now · Phase 2
Conditions studied: Metastatic Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
In brief
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).
Key facts
- Study ID
- NCT07076212
- Run by
- Medical University of South Carolina
- People needed
- 52
- Starts
- 2026-04-02
- Expected to finish
- 2029-11-01
- Last updated by the study team
- 2026-05-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged ≥18 years
- For females of reproductive potential: use of highly effective contraception for at least 1 month before screening and agreement to use such a method during study participation and for an additional 9 months after the end of the last dose of study medication administration
- Female patients including WOCBP must test negative for pregnancy at the time of screening based on a urine or serum pregnancy test.
- For males of reproductive potential: use of condoms or other methods to ensure effective contraception with a partner during the study and for 4 months after the last dose of study medication.
- Histologically or cytologically confirmed locally advanced or metastatic PDAC that has not been previously treated
- Radiographically confirmed measurable (per RECIST 1.1) locally advanced or metastatic PDAC per the National Comprehensive Cancer Network (NCCN) definition.
- Inoperable status due to the presence of locally advanced, unresectable disease with or metastases.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Hematological, biochemical, and organ function inclusion criteria:
- Absolute neutrophil count (ANC) ≥1500/mm3 without the use of hemopoietic growth factors within 7 days before treatment
- Platelet count ≥100,000/mm3.
- International normalized ratio (INR) <1.5 unless the patient is receiving anticoagulation therapy, in which case a therapeutic INR is acceptable. Anticoagulation therapy with low-molecular weight heparin or warfarin, whether medically indicated, is permitted.
- Adequate renal function, as evidenced by serum/plasma creatinine level <1.6 mg/dL
You may not qualify if…
- Pregnancy or lactation
- Treatment with another investigational drug or other intervention within 30 days of protocol initiation.
- Known hypersensitivity/allergic reaction to any of the components of the therapeutic agents in mGAP or NALIRIFOX.
- Any other medical or social condition deemed by the investigator to be likely to interfere with a subject's ability to sign informed consent, cooperate, and participate in the study or who is likely to interfere with the interpretation of the results.
- Unwilling or unable to comply with study procedures and/or study visits.
- Uncontrolled, active infection
- Histologic diagnosis other than adenocarcinoma.
- Medical co-morbidities, that preclude major abdominal surgery
Where it is running
- Hollings Cancer Center at Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- Medical University of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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