Evaluating NALIRIFOX vs Modified Gemcitabine, Nab-Paclitaxel and Cisplatin in Patients With Locally Advanced and Metastatic Pancreatic Adenocarcinoma
Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jul 14, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is testing two different chemotherapy treatments—called NALIRIFOX and a combination of gemcitabine, nab-paclitaxel, and cisplatin (mGAP)—in adults who have a type of pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The goal is to see which treatment works better for patients who have not received any prior therapy for their cancer.
Adults aged 18 and older with confirmed locally advanced or metastatic pancreatic cancer may be eligible to join, provided they are generally healthy enough for treatment and able to follow the study’s requirements. Women who could become pregnant and men with partners who could become pregnant must use effective birth control during the study and for some time afterward. Participants will receive one of the two treatment options, and doctors will monitor their health and cancer closely throughout the study. It’s important to note that this study is not yet recruiting, and people with certain conditions—like active infections, pregnancy, or other serious health problems—may not be able to join.
Gender
ALL
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 NCCN 2.2021 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
About Medical University Of South Carolina
The Medical University of South Carolina (MUSC) is a leading academic health center dedicated to advancing medical research and improving patient care through innovative clinical trials. With a strong emphasis on translational medicine, MUSC leverages its extensive resources and expertise to facilitate groundbreaking studies across various medical disciplines. The institution is committed to fostering collaboration among researchers, healthcare professionals, and patients, ensuring that cutting-edge discoveries translate into effective treatments. As a pioneer in health education and research, MUSC plays a vital role in shaping the future of medicine and enhancing health outcomes in the community and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Charleston, South Carolina, United States
Patients applied
Trial Officials
Toros Dincman, M.D., Ph.D.
Principal Investigator
Medical University of South Carolina
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported