Surgery for Liver Metastases From PDAC

Dissemination from pancreatic ductal adenocarcinoma (PDAC) occurs in clinical practice either in the form of recurrence after initial treatment with curative intent resection (metachronous) or more frequently prevails already at the time of diagnosis (synchronous). Traditionally, metastatic pancreatic cancer (mPDAC) is considered not to be eligible for meaningful aggressive therapies to be implemented. However, with the development of local as well as more effective systemic therapeutic regimens a variety of clinical situations have to be reevaluated. For instance, recent reports have indicated an option for maintained or even prolonged survival after resections and/or ablations of oligometastatic pancreatic cancer (OMDPDAC), as represented by a single or few liver metastasis (es). These reports are burdened by methodological weaknesses such as being retrospective, single institution and reporting only from highly selected case series. A common denominator of acceptable outcome is, however, that all metastatic lesions have been preoperatively treated and responded to chemotherapy, indicating an advantageous tumor biology. Hence an unbiased approach, including neo-adjuvant chemotherapy before any aggressive local treatment must be explored to the updated management opportunities in terms of assessing the prevalence, safety, feasibility, tolerability and possible disease control options. Primary objective (clinical): To prospectively investigate (on an intention to treat basis) the safety, feasibility, tolerability and clinical outcomes of all patients with PDAC presenting with limited metastatic disease, where a treatment option can be launched with the ambition of local disease control and eventually better survival. The cohorts to be included are: Primary cohort: Patients with liver limited (metachronous and synchronous) metastasis(es) due to PDAC. This cohort is further subdivided to: Limited liver disease. Extended liver disease. Secondary cohort: Patients with OMDPDAC and at least one extrahepatic manifestation of PDAC. Secondary objective (translational) is to improve the understanding of PDAC liver metastases biology by studying the mechanistic aspects of metastases invasion as well as intra- and peri-tumoral liver metastatic niche, and by charting the cellular composition of liver metastases on single cell level with a focus on the impact of cellular interactions on tumor cell growth and differentiation. Furthermore, the study aims to identify blood-based biomarkers of response to oncologic/surgical treatment.

NCT Number	NCT05271110
Lead Sponsor	Linkoeping University Collaborators: Lund University, Sahlgrenska University Hospital, Karolinska University Hospital, Uppsala University Hospital, University Hospital, Umeå, University of Southern Denmark, University of Copenhagen, Oslo University Hospital
Conditions	Disseminated Pancreatic Cancer
Enrollment	64 participants
Start Date	2022-03
Primary Completion	2025-03 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2022-03-08