This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). The primary objective of the study is to evaluate the safety of Alpha DaRT in combination with chemotherapy, based on the cumulative incidence rate, severity and outcome of device related AEs. Classification of AEs will be done according to CTCAE V5. The secondary objectives of the study are to:
* Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by overall and progression-free survival. * Assess pain control * Assess rate of surgical resection in Cohort 1.
Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/or cytologically proven newly diagnosed metastatic pancreatic adenocarcinoma (Cohort 2).
Patients will start treatment with mFOLFIRINOX (up to 4 cycles) before DaRT insertion
Target lesion is technically amenable for Alpha DaRT sources implantation.
Measurable lesion per RECIST (version 1.1) criteria
For Cohort 1 only: Borderline unresectable pancreatic cancer, and/or fit for surgical exploration unless patient refuses surgery.
For Cohort 1 and Cohort 2: Prior treatment for pancreatic cancer, including chemotherapy except for 1 - 4 cycles of mFOLFIRINOX, radiation therapy, immunotherapy, etc.
Known hypersensitivity to any of the components of the treatment.
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
Alpha Tau Medical LTD.
Lead sponsor