Resection/Synchronous Pulmonary or Hepatic Oligometastatic Pancreatic Ductal Adenocarcinoma
United States40 participantsStarted 2026-03-02
Plain-language summary
This is a clinical trial that tests a surgical treatment. Everyone in the study will get the same treatment, and there is no comparison or placebo group.
Patients can join the study if they have pancreatic cancer that has spread to only a few spots in the liver or lungs. They must be receiving a type of chemotherapy called NALIRIFOX before surgery (this is called neoadjuvant chemotherapy).
If the cancer gets worse during or after the first 4 cycles of chemotherapy, the patient will be removed from the study.
If the cancer stays the same or gets smaller after the first 4 cycles, doctors will check if the main tumor can be removed with surgery. If the tumor cannot be removed, the patient will get 4 more cycles of chemotherapy as standard of care.
If the main tumor can be removed, the patient will have surgery 2-6 weeks after finishing chemotherapy. During surgery, doctors will try to remove both the main tumor and the small tumors in the liver or lungs. If, during surgery, the doctor finds that the main tumor actually cannot be removed, the patient may receive 4 more cycles of chemotherapy starting 2-4 weeks after surgery.
Who can participate
SexALL
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Inclusion criteria
✓. Histologically confirmed diagnosis of treatment-naïve limited hepatic or pulmonary metastatic adenocarcinoma of the pancreas
✓. Meet the definition of limited hepatic or pulmonary metastasis according to Computed Tomography/Magnetic Resonance Imaging (CT/MRI) that is done prior to the starting of any anticancer treatment. Either CT scan of chest, abdomen, and pelvis with intravenous contrast or a combination of MRI of abdomen and pelvis and CT scan of chest is acceptable radiographic imaging. CT/MRI can be done at an outside facility but must be reviewed by a local radiologist.
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
✓. Patients ≥18 years at the time of signing the informed consent
✓. Being a candidate for chemotherapy with NALIRIFOX
✓. Patient's written informed consent prior to any trial-specific procedure
✓. Patient's legal capacity to consent to participation in the clinical trial.
Exclusion criteria
✕. Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
✕. Symptomatic clinically significant ascites
What they're measuring
1
Efficacy of R0/R1 resection
Timeframe: Prior to surgery to 4-12 weeks after surgery
Trial details
NCT IDNCT07340151
SponsorThe University of Texas Health Science Center at San Antonio
✕. Evidence of any distant metastases other than limited hepatic or pulmonary metastasis as defined in inclusion criterion 1.
✕. Evidence of simultaneous pulmonary and hepatic metastases
✕. Any tumor-specific pretreatment of the adenocarcinoma of the pancreas (including but not limited to surgery, radiation therapy, chemotherapy or ablative procedures). Currently being on NALIRIFOX or its modified form is allowed, unless more than 2 treatments of NALIRIFOX have been given.
✕. Any malignancies other than adenocarcinoma of the pancreas in the 2 years before the start of the clinical trial except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, breast cancer, prostate cancer or superficial bladder tumors (Ta, Tis and T1 staging where Ta=non-invasive; Tis=high-grade, flat non-invasive cancer in situ; T1=relatively small primary tumor that has not spread to surrounding tissues)
✕. Known Human immunodeficiency virus (HIV) seropositivity
✕. Known active or chronic Hepatitis B or Hepatitis C infection