Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

- Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma

- Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery

- ECOG performance status ≤ 2

- Measurable lesion per RECIST (version 1.1) criteria

- Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes)

- ≥ 18 years of age

- Estimated life expectancy of at least 12 weeks

- Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test

- Subjects are willing to sign an informed consent

- Prior chemotherapy does not exclude the patient

- Prior abdominal radiation therapy

- Concomitant chemotherapy or immunotherapy

- Borderline resectable pancreatic cancer and medically fit for surgery

- Connective tissue disease (scleroderma, lupus)

- Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)

- Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids

- Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT

- High probability of protocol non-compliance (in opinion of investigator)

- Patients not willing to sign an informed consent form

- Women who are pregnant or lactating