What side effects are associated with this type of intervention?

Common treatments for liver cancer, such as stereotactic body radiation therapy (SBRT) and transcatheter arterial chemoembolization (TACE), can have several side effects. SBRT may cause fatigue, nausea, liver toxicity, and gastrointestinal issues such as gastroduodenal ulcers. TACE can lead to post-embolization syndrome, characterized by pain, fever, and nausea, as well as liver dysfunction and elevated bilirubin levels. While histotripsy, a non-invasive focused ultrasound therapy, is still under investigation, it aims to minimize these side effects by mechanically destroying targeted tissues without the need for incisions or radiation.

What prior FDA approvals exist?

The FDA has approved several treatments for liver cancer, including targeted therapies, immunotherapies, and locoregional treatments. Sorafenib (Nexavar) and lenvatinib (Lenvima) are oral tyrosine kinase inhibitors approved for advanced hepatocellular carcinoma (HCC). Regorafenib (Stivarga) and cabozantinib (Cabometyx) are approved for patients who have previously been treated with sorafenib. Immunotherapy options include nivolumab (Opdivo) and pembrolizumab (Keytruda), which are PD-1 inhibitors. Locoregional treatments like transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) are also commonly used. While histotripsy itself is not yet FDA-approved, these treatments reflect the range of current therapeutic strategies for liver cancer.

What other types of research exist?

Promising novel alternatives to the HistoSonics System for liver cancer treatment include: 1) Imatinib, a selective tyrosine kinase inhibitor, particularly effective for gastrointestinal stromal tumors (GISTs) and certain histologic soft tissue tumor types. 2) Trabectedin, approved for advanced leiomyosarcoma and liposarcoma, showing efficacy in patients previously treated with anthracycline-containing regimens. 3) Chemotherapy with regional hyperthermia, which has shown benefits in European trials for large high-grade tumors or initially unresectable disease. These alternatives offer different mechanisms of action and may be considered based on the specific type and stage of liver cancer.

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Procedure

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

Q: What is the mechanism of action of this treatment?

Common treatments for liver cancer include surgical resection, radiation therapy (such as proton beam irradiation and stereotactic body radiation therapy), and systemic therapies (like chemotherapy and immunotherapy). Histotripsy, a non-invasive focused ultrasound therapy, mechanically destroys targeted tissues through precise acoustic energy, offering a promising alternative by minimizing damage to surrounding healthy tissues. This is particularly significant for liver cancer patients as it potentially reduces treatment-related complications and preserves liver function, which is crucial given the liver's vital role in metabolism and detoxification.

N/A

Waitlist Available

Led By Timothy J Ziemlewicz, MD

Research Sponsored by HistoSonics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Renal function: serum creatinine <2x ULN

Subject is diagnosed with hepatocellular carcinoma (HCC) or liver metastases (mets) from other primary cancers

Must not have

Targeted tumor(s) treatment volume overlaps a non-targeted tumor visible via imaging

Subject has a history of, or suspected to have, bleeding disorders that are uncorrectable

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ≤36 hours post-index procedure

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of the HistoSonics Histotripsy may include pain at the treatment site, bruising, bleeding, inflammation around the treated area, and possible damage to nearby tissues or organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

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

Select...

My tumor is 3 cm or smaller.

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I can safely be put under general anesthesia.

Select...

My liver function is mild to moderately impaired.

Select...

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

Select...

I have up to 3 tumors eligible for histotripsy treatment.

Select...

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

Select...

My liver tests are within normal limits.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

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I have a bleeding disorder that cannot be corrected.

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

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

Select...

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

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

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I am eligible for surgery to remove my cancer.

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

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

Select...

My blood does not clot properly and cannot be corrected.

Select...

My cancer treatment targets areas near important digestive system parts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ≤36 hours post-index procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~≤36 hours post-index procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and ≤36 hours post-index procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Efficacy: Technical Success

Primary Safety: Procedure-Related Major Complications

Secondary study objectives

Procedure-Related Major Complications

Secondary Efficacy: Technique Efficacy

Secondary Safety: All Adverse Events

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HistoSonics SystemExperimental Treatment1 Intervention

0 / 20Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cancer include surgical resection, radiation therapy (such as proton beam irradiation and stereotactic body radiation therapy), and systemic therapies (like chemotherapy and immunotherapy). Histotripsy, a non-invasive focused ultrasound therapy, mechanically destroys targeted tissues through precise acoustic energy, offering a promising alternative by minimizing damage to surrounding healthy tissues. This is particularly significant for liver cancer patients as it potentially reduces treatment-related complications and preserves liver function, which is crucial given the liver's vital role in metabolism and detoxification.