Study of Alpha DaRT Device with Chemotherapy for Treating Locally Advanced Pancreatic Cancer

What this Trial Is About

Researchers are evaluating a new cancer treatment approach using radioactive Alpha DaRT sources coated onto stainless steel tubes for patients with locally advanced pancreatic cancer. This prospective, interventional, open-label, single-arm study involves patients previously treated with 8 to 12 cycles of mFOLFIRINOX chemotherapy. The goal is to assess whether the DaRT treatment can make tumors operable and improve patient outcomes. Participants will receive the DaRT seeds implanted directly into their tumors. Three days after implantation, they will begin taking Capecitabine orally for two months. Every two months, patients will be evaluated to determine if their tumor has become surgically removable, whether to continue therapy, or to pause treatment. The study lasts for 12 months after DaRT insertion. During the study, participants will undergo regular assessments including tumor measurements and safety monitoring for serious adverse events. Researchers will track tumor response, overall survival, progression-free survival, and the percentage of patients who achieve successful tumor removal. Safety and treatment effects will be monitored for up to one year following treatment initiation.

Alpha Radiation Emitters Device (DaRT) for the Treatment of Locally Advanced Pancreatic Cancer