Surgery Versus Palliative Care for Pancreatic Cancer with Limited Liver Metastases after Chemotherapy A Phase 2 International Randomized Trial

What this Trial Is About

This research investigates the role of surgical removal compared to palliative care in patients with pancreatic cancer that has spread to the liver but remains limited in number oligometastatic. The study focuses on whether surgery after stable disease or a positive response to chemotherapy can improve survival and quality of life in these patients. This international, multicenter randomized controlled trial aims to provide clearer evidence on the best approach for managing this aggressive cancer stage. Participants will be randomly assigned to one of two groups. One group will have surgery to remove both the primary pancreatic tumor and liver metastases, with the surgical approach tailored by each centers protocols. Some liver lesions under 20 mm may be treated with needle ablation or microwave techniques. Postoperative chemotherapy or radiotherapy may be given based on individual cases. The other group will continue with palliative care, including observation or ongoing chemotherapy according to the physicians choice and prior treatment, following approved protocols. Throughout the study, participants will have regular clinical evaluations, lab tests, and imaging scans such as abdominal and chest CTs every 8-12 weeks. Quality of life and nutritional status will also be assessed. The primary outcome measured is survival two years after randomization, with secondary outcomes including progression-free survival, surgical complications, cancer-related quality of life, and treatment-related side effects. The minimum follow-up period is two years from enrollment.

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