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Evaluating NALIRIFOX vs mGAP for Pancreatic Cancer

This study is testing two different chemotherapy combinations for people with pancreatic cancer that is locally advanced (meaning it hasn't spread far) or metastatic (meaning it has spread to other parts of the body). One combination is called NALIRIFOX, which includes Liposomal Irinotecan, Oxaliplatin, 5-Fluorouracil, and Leucovorin. The other combination is called mGAP, which includes Gemcitabine. The goal is to see which treatment is more effective at shrinking the cancer, measured by how many patients respond to the treatment. This study is for adults aged 18 and older who have not received treatment for their pancreatic cancer before. The study aims to enroll 52 participants.

Study design
This is a Phase 2, single-center, open-label, randomized study comparing two treatment arms. It plans to enroll 52 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your response to treatment will be measured for up to 30 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07076212

Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

Recruiting
PHASE2Ages 18+InterventionalTreatment
Medical University of South Carolina
~52 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:Liposomal IrinotecanOxaliplatin5-FluorouracilLeucovorinGemcitabine (mg/m²)Nab-paclitaxel

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall response rate (ORR) assessed by imaging.
Measured over Up to 30 months

Conditions

Metastatic Pancreatic Adenocarcinoma
Locally Advanced Pancreatic Adenocarcinoma

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Pancreatic Adenocarcinoma

NCT07076212

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Hollings Cancer Center at Medical University of South Carolina

    Charleston, South Carolinastudy coordinator listed

    Recruiting

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Albert Lockhart, MD · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

HCC Clinical Trials Office, MD
[email protected]
843-792-9321
Email the study team

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Eligibility criteria

Inclusion

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
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

Exclusion

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

What this trial measures

  • Overall response rate (ORR) assessed by imaging.Up to 30 months

    Overall response rate (ORR) defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) by RECIST v1.1 as assessed by imaging completed every 8 weeks.