Comparing two Chemotherapy Regimens (NALIRIFOX and mGAP) in the Treatment of Locally Advanced, Unresectable, and Metastatic Pancreatic Adenocarcinoma

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 women of childbearing potential (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 Response Evaluation Criteria in Solid Tumors [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 metastases
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Absolute neutrophil count (ANC) >= 1500/mm^3 without the use of hemopoietic growth factors within 7 days before treatment
• Platelet count >= 100,000/mm^3
• 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