Conversion Surgery Vs. Palliative Care in Pancreatic Cancer Oligometastatic to the Liver

Prior treatment

• Presence of significant comorbidities precluding surgery.
• Contraindications to surgical resection.
• Prior surgical resection of the primary tumor or liver metastases.

Other illness

• Locally advanced pancreatic cancer according to NCCN4.
• Unresectable liver disease (according to multidisciplinary discussion).
• Disease progression as determined by RECIST 1.1 criteria21 (modified to include any % of increase in the sum of diameters of target lesions) after chemotherapy.

Lab values

• Serum CA19-9 level increase \>20% after chemotherapy.
  • Note: Additional specific exclusion criteria may be defined at each participating center based on their institutional guidelines and patient population.

Other

• Involvement of other organs.
• Pregnancy.
• Evidence of extrahepatic metastases.
• Inability to provide informed consent or participate in follow-up assessments.

• Adult patients aged ≥18 years and ≤75 years (at diagnosis).
• Cytologically or histologically confirmed pancreatic adenocarcinoma either resectable or borderline resectable (at diagnosis) according to National Comprehensive Cancer Network (NCCN)4 (see section 5).
• Synchronous oligometastatic disease (at diagnosis), defined as a limited number of radiologically documented liver metastases (up to 3 lesions).
• No evidence of extrahepatic metastases (at diagnosis.)
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 (at enrollment)
• Partial response or stable disease after completion of first-line chemotherapy, as determined by RECIST 1.1 criteria21 (modified to exclude any % of increase in the sum of diameters of target lesions) (at enrollment).
• Decreasing or stable (defined as ≤20% increase) serum CA19-9 level after chemotherapy (at enrollment).
• Liver metastases considered resectable (see section 5) or alternatively treatable by needle ablation/microwave once no larger than 20 mm (at enrollment).