This is a multi-center clinical study enrolling up to 50 participants. 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 V6. 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.
Parallel
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceDaRT source will be inserted using endoscopy into the tumor. The sources release by recoil into the tumor short-lived alpha-emitting atoms
Safety -Serious adverse events
The primary endpoint is to evaluate the safety of Alpha DaRT in combination with chemotherapy based on the cumulative incidence rate of treatment-related Serious Adverse Events (SAEs) graded according to CTCAE v6.0
Complete or pain response
Complete or partial pain response at 30 days and 2 months postprocedure as compared to baseline based on average pain scale using BPI-SF (Brief Pain Inventory - Short Form) used to evaluate the severity of a patient's pain, 0-no pain, 1 to 3- mild pain, 4 to 7- moderate pain, 8 to 10- severe pain .
Percentage of locally advanced that became surgically resectable
For cohort 1 only: Percentage of locally advanced patients with tumors that became surgically resectable after DaRT treatment
Progression-free survival using RECIST V1.1
Assess efficacy of the Alpha DaRT sources in combination with chemotherapy, determined by progression-free survival
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