Alpha Radiation Emitters for Pancreatic Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults with newly diagnosed, inoperable locally advanced or metastatic pancreatic adenocarcinoma. Participants must have started chemotherapy with mFOLFIRINOX, have a measurable lesion that's ≤5 cm and can be implanted with Alpha DaRT sources. They should be relatively fit (ECOG 0-2), expected to live more than 6 months, and meet certain blood cell count criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive mFOLFIRINOX treatment and undergo DaRT placement during the first 4 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for long-term safety and survival outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alpha Tau Medical LTD.
Lead Sponsor