Histotripsy with HistoSonics System for Liver Cancer

(#HOPE4LIVER US Trial)

Not currently recruiting at 6 trial locations

Overseen By Christine Sullivan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: HistoSonics, Inc.

Must not be taking: Bevacizumab, Chemotherapy, Immunotherapies, others

Disqualifiers: Pregnancy, Bleeding disorders, others

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

Compensation: Varies

Number of Visits: 2

Duration: ≤36 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the HistoSonics System, a non-invasive therapy, to determine its safety and effectiveness for liver cancer. It targets individuals with liver tumors, either primary (originating in the liver) or metastatic (spread from other areas), who have not found success with other treatments. To participate, individuals should have liver tumors no larger than 3 cm, be able to undergo anesthesia, and not have responded to other therapies. The trial will assess the system's effectiveness and safety for patients. As an unphased trial, it offers a unique opportunity to access innovative treatment options not available elsewhere.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, if you are on investigational medications or certain cancer treatments like bevacizumab, chemotherapy, or immunotherapy, you may need to stop them for a specified period before the procedure.

What prior data suggests that the HistoSonics System is safe for treating liver cancer?

Research shows that the HistoSonics System, used to treat liver tumors, is generally well-tolerated. Studies have found that only 6.8% of patients experience complications, and serious issues are rare, indicating that the treatment is quite safe compared to other options.

The treatment has been tested on patients with both primary and metastatic liver cancer. Early trial results demonstrate a good safety record, with few complications overall. Therefore, prospective participants can consider this information as evidence of the treatment's relative safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The HistoSonics System is unique because it uses a technique called histotripsy, which is a non-invasive, focused ultrasound technology. Unlike traditional treatments for liver cancer, such as surgery, chemotherapy, or radiofrequency ablation, histotripsy mechanically disrupts cancer cells without heat, incisions, or radiation. This approach minimizes damage to surrounding healthy tissues and reduces recovery time. Researchers are excited about its potential to offer a safer, more precise option for patients with liver cancer, potentially improving outcomes and quality of life.

What evidence suggests that the HistoSonics System is effective for liver cancer?

Studies have shown that the HistoSonics System holds promise for treating liver tumors. In a previous study, participants achieved a 90% success rate in controlling their tumors after 12 months. Another trial found a 95.5% success rate in treating liver cancer, which is notably high. The same study reported a low complication rate of 6.8%, indicating relative safety. The system uses sound waves to break down cancer cells, which may explain its effectiveness. Participants in this trial will receive treatment with the HistoSonics System to further evaluate its effectiveness and safety. ^{1 2 4 5 6}

Who Is on the Research Team?

Timothy J Ziemlewicz, MD

Principal Investigator

University of Wisconsin, Madison

Clifford S Cho, MD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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 meet the health requirements set within the last week.

My tumor is 3 cm or smaller.

Exclusion Criteria

Subject has a concurrent condition that, in the investigator's opinion, could jeopardize the safety of the subject or compliance with the protocol

I was treated with bevacizumab and stopped it less than 40 days ago.

Subject is pregnant or planning to become pregnant or nursing (lactating) during the trial period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive histotripsy treatment for liver tumors using the HistoSonics System

≤36 hours

1 visit (in-person)

Initial Follow-up

Participants are monitored for safety and efficacy, including imaging to assess technical success

30 days

1 visit (in-person)

Extended Follow-up

Participants are evaluated at 6 months and followed annually for up to five years post-index procedure

5 years

What Are the Treatments Tested in This Trial?

Interventions

• HistoSonics System

Trial Overview 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.

How Is the Trial Designed?

Group I: HistoSonics System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

HistoSonics, Inc.

Lead Sponsor

Trials

9

Recruited

5,200+

Citations

1. fusfoundation.org fusfoundation.org/posts/histotripsy-for-liver-tumors-one-year-data-suggest-90-tumor-control/

Histotripsy for Liver Tumors: One-Year Data Suggest 90% ... Researchers found that after 12-months, participants experienced a 90% local tumor control rate across all treated tumors regardless of tumor type or origin.

2. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.233051

The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy ... The pooled #HOPE4LIVER trials demonstrated the safety and technical success of the HistoSonics System for the destruction of liver tumors using histotripsy.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469116/

Histotripsy: Recent Advances, Clinical Applications, and ... Furthermore, the #HOPE4LIVER trial reported a 95.5% efficacy rate and a 6.8% complication rate in treating hepatocellular carcinoma and liver ...

4. histosonics.com histosonics.com/news/fda-awards-histosonics-clearance-of-its-first-of-a-kind-edison-histotripsy-system-2/

FDA Awards HistoSonics Clearance of its First-of-a-Kind ... As recently presented at the annual CIRSE Congress in Copenhagen, a technical success rate of 95.5% was achieved indicating that physicians can ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1091255X25000599

The first international experience with histotripsy: a safety ... Histotripsy was first used in humans in 2020, but only 3 studies (53 patients) have reported the clinical outcomes of histotripsy treatment of liver tumors to ...

6. histosonics.com histosonics.com/news/histosonics-announces-published-results-of-phase-i-liver-tumor-trial/

HistoSonics Announces Published Results of Phase I Liver ... View results from our Phase I clinical trial. This study observed tumors in eight patients who had unresectable end-stage multifocal liver ...