Comparing NALIRIFOX to a modified gemcitabine/nab‑paclitaxel/cisplatin regimen for advanced pancreatic adenocarcinoma

Phase II Study Evaluating NALIRIFOX Versus Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma

This compares NALIRIFOX to a modified gemcitabine/nab‑paclitaxel/cisplatin regimen to see if it helps people with untreated locally advanced or metastatic pancreatic ductal adenocarcinoma live longer or have better tumor responses.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of South Carolina (other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Charleston, South Carolina and 1 other locations)
• Trial ID: NCT07076212 on ClinicalTrials.gov

What this trial studies

This is a single‑center, open‑label, randomized Phase 2 trial that assigns previously untreated adults with locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma to receive either NALIRIFOX or a modified gemcitabine/nab‑paclitaxel/cisplatin regimen. Patients must have histologic or cytologic confirmation and measurable disease per RECIST 1.1. The trial follows standard chemotherapy dosing schedules and monitors objective response, progression‑free survival, overall survival, and safety. Findings will be compared to historical outcomes for established regimens such as FOLFIRINOX and gemcitabine‑based combinations.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically or cytologically confirmed, previously untreated locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma with measurable disease and adequate organ function are the intended participants.

Not a fit: Patients who have received prior systemic therapy for their pancreatic cancer, have resectable disease, poor performance status, or significant comorbidities are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the regimen could offer a more effective first‑line chemotherapy option that increases response rates and extends progression‑free and overall survival.

How similar studies have performed: Prior randomized data have shown higher objective response rates and improvements in PFS and OS with NALIRIFOX versus gemcitabine plus nab‑paclitaxel, and FOLFIRINOX has previously demonstrated benefit over single‑agent gemcitabine.

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

Where this trial is running

Charleston, South Carolina and 1 other locations

• Hollings Cancer Center at Medical University of South Carolina — Charleston, South Carolina, United States (RECRUITING)
• Medical University of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Albert Lockhart, MD — Medical University of South Carolina
• Study coordinator: HCC Clinical Trials Office, MD

Conditions: Metastatic Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma