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
Parallel
Surgical resection
Procedure/SurgeryPatients with a technically resectable primary tumor and tumor response or stable disease of their metastatic disease according to the evaluation of an interdisciplinary tumor board after the first 4 cycles will undergo exploratory laparotomy and synchronous or staged resection of the primary tumor and the hepatic or pulmonary metastases by using the standard of care surgical techniques 2-6 weeks after the last neoadjuvant chemotherapy. Residual tumor classification, also known as R Classification defines how complete the resection of the malignancy has been at surgery: R0: no residual tumor/R1: microscopic residual tumor
Efficacy of R0/R1 resection
Assessed by tumor imaging
Safety of surgical resection of synchronous pulmonary or hepatic oligometastatic ductal adenocarcinoma
Surgical complications will be defined based on Clavien-Dindo classification and will be monitored continuously. The monitoring rule will focus on Grade IIIa surgical complication or above deemed related to the chemotherapy regimen (liposomal irinotecan, oxaliplatin, 6-fluorouracil/folinic acid) which is beyond what may be expected for chemotherapy or resection without immunotherapy.
European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ-30)
The QLQ-C30 is composed of both multi-item scales and single-item measures including 5 functional scales, 3 symptom scales, a global health status / QoL scale, and six single items. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. A crucial Summary Score (0-100) combines 13 scales (excluding Global QoL \& Financial Impact), with higher scores indicating better overall quality of life. Scoring requires specific formulas from the official manual, with procedures for handling missing data and ensuring consistency across different scales, often involving reversing symptom scales for uniform interpretation.
European Organization for Research and Treatment of Cancer Quality of Life for pancreatic ductal adenocarcinoma (EORTC QLQ-PAN26)
Raw scores from the questionnaire items (e.g., 1=Not at all, 4=Very much) are linearly transformed to a 0-100 scale. Higher score on a symptom scale = Worse symptoms/more problems (e.g., pancreatic pain). Higher score on a functional scale = Better quality of life/functioning (e.g., planning activities)
Progression-free survival (PFS)
Assessment of mortality of participant continuously post surgery until study end.
Time to development of new/recurrent metastases
Time to diagnosis of any new metastases or recurrence of resected tumor
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