Alpha Radiation Emitters (DaRT) With Chemotherapy for the Treatment of Locally Advanced and Metastatic Pancreatic Cancer

This is a multi-center clinical study enrolling up to 30 participants (15 patients in each cohort). 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 V5. 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.

Trial Details

NCT ID
NCT06698458
Phase
NA
Sponsor
Alpha Tau Medical LTD.
Status
RECRUITING
Cancer Type
Pancreatic Cancer
Interventions
  • Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Locations (sample)
  • Gilbert, Arizona, United States|33.35283,-111.78903
  • Goodyear, Arizona, United States|33.43532,-112.35821
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orlando, Florida, United States|28.53834,-81.37924

Key Eligibility Criteria

  • Histologically and/or cytologically proven newly diagnosed locally advanced inoperable pancreatic adenocarcinoma (Cohort 1) OR histologically and/o…
  • 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 full eligibility, visit ClinicalTrials.gov.

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