Alpha Radiation Emitters for Pancreatic Cancer

Recruiting at 15 trial locations

Overseen By Liron Dimnik

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Alpha Tau Medical LTD.

Must be taking: mFOLFIRINOX

Must not be taking: Immunosuppressants

Disqualifiers: Cardiovascular disease, Uncontrolled illnesses, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 2 months

30 Participants Needed

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

My cancer can be measured using standard imaging techniques.

My team of doctors has approved me for a specific type of radiation therapy.

My white blood cell count is healthy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mFOLFIRINOX treatment and undergo DaRT placement during the first 4 cycles

Approximately 2 months

Multiple visits for chemotherapy cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Long-term follow-up

Participants are monitored for long-term safety and survival outcomes

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Diffusing Alpha Radiation Emitters Therapy (DaRT)

Trial Overview The study tests the safety and effectiveness of Alpha Radiation Emitters Therapy (DaRT) combined with chemotherapy in treating pancreatic cancer. It aims to see how well it works by looking at survival rates, pain control, and whether patients become eligible for surgery after treatment.

How Is the Trial Designed?

Group I: Patients with metastatic pancreatic adenocarcinoma Experimental Treatment 1 Intervention

Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

Group II: Patients with locally advanced pancreatic adenocarcinoma Experimental Treatment 1 Intervention

Patients will begin mFOLFIRINOX treatment and will undergo DaRT placement during the first 4 cycles. Follow-up will continue up to 6 months after enrollment.

Who Is Running the Clinical Trial?

Alpha Tau Medical LTD.

Lead Sponsor

Trials

28

Recruited

920+