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.
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.
Definition of limited hepatic metastasis: 1 to 5 metastases in CT/MRI, which are potentially resectable or treatable by ablative procedures.
Note 1: Patients also fulfil this inclusion criterion if a hepatic metastasis was partly or entirely removed as part of the diagnosis and is thus not detectable by CT/MRI scan at screening.
Acinar cell carcinoma and/or neuroendocrine carcinoma of the pancreas
Symptomatic clinically significant ascites
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