NCT07076212 Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
| NCT ID | NCT07076212 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Medical University of South Carolina |
| Condition | Metastatic Pancreatic Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-04-02 |
| Primary Completion | 2028-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 52 participants in total. It began in 2026-04-02 with a primary completion date of 2028-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Albert Lockhart, MD
PRINCIPAL INVESTIGATOR
Medical University of South Carolina
Frequently Asked Questions
Who can join the NCT07076212 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Pancreatic Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07076212 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07076212 currently recruiting?
Yes, NCT07076212 is actively recruiting participants. Contact the research team at hcc-clinical-trials@musc.edu for enrollment information.
Where is the NCT07076212 trial being conducted?
This trial is being conducted at Charleston, United States, Charleston, United States.
Who is sponsoring the NCT07076212 clinical trial?
NCT07076212 is sponsored by Medical University of South Carolina. The principal investigator is Albert Lockhart, MD at Medical University of South Carolina. The trial plans to enroll 52 participants.