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 the incidence , rate and severity of treatment- emergent Adverse Events (TEAS) graded according to CTCAE V6.0.
Overall survival
Overall survival - measured as the time from DaRT insertion to death or last survival follow-up.
Progression-free survival
measured as the time from DaRT insertion to the first documentation of progression, excluding surgery enabled after tumor was deemed resectable or up to last-follow-up up.
Complete or partial response
30 days and 2 months post-procedure as compared to baseline based on average pain scale using BPI-SF
For Cohort 1 only: Percentage of locally advanced
patients with tumors that became surgically resectable after DaRT treatment
Click on the lead sponsor to view all of their trials.
