Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer

Launched by ALPHA TAU MEDICAL LTD. · Jun 27, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method for advanced pancreatic cancer using a special device that delivers alpha radiation directly into tumors. This innovative approach aims to help patients with pancreatic cancer that cannot be surgically removed, whether because it's too advanced, has spread to other areas, or the patient isn’t healthy enough for surgery. The trial is currently recruiting participants aged 18 and older who have been diagnosed with locally advanced or metastatic pancreatic adenocarcinoma and have measurable tumors.

To be eligible, participants need to have a confirmed diagnosis of pancreatic cancer that cannot be treated with surgery, a life expectancy of at least 12 weeks, and must be able to provide informed consent. They should also not be undergoing certain other treatments that could interfere with the trial. Throughout the study, participants will receive the alpha radiation treatment and will be monitored for its effects. This trial offers a potential new hope for those facing a challenging cancer diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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