Journal of Clinical Trials
Open Access
ISSN: 2167-0870
ISSN: 2167-0870
Department of Gastrointestinal Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA
Research Article
A Multistrike Evolutionary Oncology Strategy for Locally Advanced Pancreatic Cancer: A Phase 1 Trial of Standard-of-Care Plus Irreversible Electroporation and Pembrolizumab Immunotherapy
Author(s): John Michael Bryant, Qianxing Mo, Alicia Chin, Pamela Hodul, Jason Denbo, Daniel Anaya, Jason Fleming, Jose M. Pimiento, Andrew Sinnamon, Ji Fan, Dae Won Kim, Richard Kim, Tiago Biachi de Castria, Mohammed Al-Jumayli, Martine Extermann, Christine Sam, Barbara Centeno, Krystal Villalobos-Ayala, Jennifer B. Permuth, Tomar Ghansah, Paulo C. Rodriguez, Joel S. Brown, Solomon Alhassan, Aamir Dam, Shaffer Mok, Anjuli Luthra, Saras Cappelle, Fawn D. Vigneau, Ola M. Gaber, James Costello, Bela Kis, Junsung Choi, Jessica M. Frakes, Sarah Hoffe, Robert A. Gatenby and Mokenge Malafa*
Introduction: Pancreatic Adenocarcinoma (PDAC) is one of the most lethal malignancies, with a dire need for new treatments. Locally Advanced Pancreatic Cancer (LAPC) often presents with limited therapeutic options, with median overall survival of only 6 to 11 months. Immunotherapy (IO) has shown promising results in various solid and hematological malignancies, but it is less effective in PDAC because of its immunosuppressive Tumor Microenvironment (TME) and cold tumor phenotype. This study explores the efficacy of Irreversible Electroporation (IRE) combined with IO in altering the TME, following standard-of-care Chemotherapy (CHT) and Radiation Therapy (RT), to enhance treatment response in LAPC.
Methods: This is a nonrandomized, single-arm, Phase 1 study for adult patients with histologically confirmed LAPC. The treatment involv.. View More»