Acoustic Cluster Therapy + Chemotherapy for Pancreatic Cancer

(ENACT Trial)

Overseen By Chief Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: EXACT Therapeutics AS

Must be taking: Chemotherapy

Disqualifiers: Prior pancreatic cancer treatment, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

Duration: 16 weeks

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of the study is to assess the efficacy and safety of Acoustic Cluster Therapy (ACT) when given in addition to chemotherapy for treatment of Locally Advanced Pancreatic Cancer.

Are You a Good Fit for This Trial?

This trial is for individuals with inoperable or borderline resectable locally advanced pancreatic cancer who are not candidates for primary curative surgery. Participants must be suitable to receive mFOLFIRINOX chemotherapy as determined by the study's investigator.

Inclusion Criteria

My doctor thinks I can handle mFOLFIRINOX treatment.

My pancreatic cancer cannot be removed by surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acoustic Cluster Therapy (ACT) with modified FOLFIRINOX chemotherapy in up to eight 2-week cycles

16 weeks

8 visits (in-person)

Efficacy Assessment

Objective efficacy of the treatment is assessed by CT scans

Every 8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acoustic Cluster Therapy
• Modified FOLFIRINOX

Trial Overview The trial is evaluating the effectiveness and safety of Acoustic Cluster Therapy (ACT) combined with a modified version of FOLFIRINOX chemotherapy, compared to standard treatment options for locally advanced pancreatic cancer.

How Is the Trial Designed?

Group I: Acoustic Cluster Therapy (ACT) with mFOLFIRINOX Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

EXACT Therapeutics AS

Lead Sponsor

Trials

2

Recruited

40+