Histotripsy with HistoSonics System for Liver Cancer (#HOPE4LIVER US Trial)

Palo Alto (17 mi)

Overseen byClifford S Cho, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: HistoSonics, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests a device that uses sound waves to break down liver tumors. It targets patients with liver tumors that may not respond to other treatments. The device works by creating bubbles in the tumor, which then burst and destroy the tumor cells.

Eligibility Criteria

This trial is for adults with primary liver cancer or liver metastases who haven't had success with other treatments. They must have good liver, kidney, and blood function, no more than three tumors each ≤3cm in size, and be fit enough for general anesthesia. Pregnant women or those on certain recent treatments are excluded.

Inclusion Criteria

My kidney function is normal, with creatinine levels less than twice the upper limit.

I have been diagnosed with liver cancer or cancer that has spread to my liver.

My tumor is 3 cm or smaller.

I can safely be put under general anesthesia.

My liver function is mild to moderately impaired.

I can take care of myself and am up and about more than half of the day.

I have up to 3 tumors eligible for histotripsy treatment.

My liver, kidney, and blood tests are within required ranges.

My liver tests are within normal limits.

Exclusion Criteria

My treatment is targeting a tumor that overlaps with another tumor not being specifically targeted.

I have a bleeding disorder that cannot be corrected.

I stopped my immunotherapy at least 4 weeks ago and recovered from its side effects.

I am scheduled for bevacizumab treatment before my 30-day follow-up.

I still experience side effects from cancer treatment, excluding hair loss, tiredness, nausea, vomiting, and nerve pain.

My tumor is located in a specific part of my liver.

I am eligible for surgery to remove my cancer.

My kidney function is low, with creatinine >2.0 or EGFR <30, but I may be on dialysis.

I haven't had major surgery or significant injury in the last 2 weeks, or I've fully recovered from one.

My blood does not clot properly and cannot be corrected.

My cancer treatment targets areas near important digestive system parts.

Treatment Details

The HistoSonics System's safety and effectiveness in treating liver tumors using Histotripsy—a non-invasive technique—are being tested. Participants will undergo this single-arm treatment to see how well it works against their tumors.

1Treatment groups

Experimental Treatment

Group I: HistoSonics SystemExperimental Treatment1 Intervention