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Brief Title: Electroporation Potentiated Immunotherapy in Cancer
Official Title: A Phase II Study of Electroporation Potentiated Immunotherapy in Liver Metastatic
Study ID: NCT04835402
Brief Summary: The study is investigating the efficacy and safety of combined irreversible electroporation (IRE) and checkpoint inhibition in metastatic pancreatic cancer.
Detailed Description: The aim of the study is to investigate whether checkpoint inhibition in conjunction with IRE of a single liver metastasis can elicit a systemic anticancer immune response in patients with pancreatic cancer. Adult patients, in WHO performance status 0-1, with liver metastatic pancreatic cancer, intolerant to or progressing on first or further lines of chemotherapy can enter the trial. Pembrolizumab infusion is given every six weeks for up to six months. IRE of a single liver metastasis is performed between the first and second pembrolizumab infusion. Response to the therapy is examined by CT (RECIST) on non-IRE-ablated lesions every 2 months. Assessments of changes in peripheral blood immune cell composition, tumor gene expression and tumor infiltrating lymphocytes is performed on serial biopsies and blood samples.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Department of Oncology, Aalborg, North Denmark Region, Denmark
Name: Morten Ladekarl, DMSc
Affiliation: Department of Oncology
Role: PRINCIPAL_INVESTIGATOR