A Study to Assess the Safety of Intratumoral Diffusing Alpha Radiation Emitters with Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

Brief description of study

This is a one-arm study testing whether the new treatment with Alpha DaRT (a medical device fitted inside the tumor that emits radiation), together with mFOLFIRINOX( a standard chemotherapy), is more effective and with fewer side effects in patients with advanced pancreatic cancer or those patients whose pancreatic cancer has spread from its primary location. Alpha DaRT is a medical device that emits radiations that help kill cancer cells.

Patients will be divided into two groups based on whether their cancer has spread from its original location or has spread from its primary location to other distant parts of the body. Both these groups of patients will get the standard chemotherapy and will have the study device called Alpha DaRT inserted into their tumor.

The study team will take blood samples from all patients to see how they are doing . All patients will have special scans taken to see how their cancer is responding to the study treatment. All patients will be closely monitored for side effects and safety, and followed up to two years after the last treatment dose.


Clinical Study Identifier: s25-00198
ClinicalTrials.gov Identifier: NCT06698458
Principal Investigator: Tamas A Gonda.
Other Investigators: Gil'ad N. Cohen, Daniel J Becker, Paul E. Oberstein, Kristen Spencer, Colin Hill, Nina Beri, Jennifer Chuy, Isabella Duarte, Rafael Winograd, Shun Yu, Fauzia Shaikh.


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