Histotripsy + Chemotherapy for Liver Metastases from Colorectal Cancer

Overseen By Erlind Allkushi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Comprehensive Cancer Center

Must be taking: Chemotherapy

Disqualifiers: Resectable disease, Extra-hepatic disease, Childs C Cirrhosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether combining histotripsy—a non-invasive treatment using sound waves to break down tumors—with chemotherapy can improve the treatment of liver metastases from colorectal cancer. The focus is on cases where the cancer has spread to the liver but cannot be surgically removed. Participants receive both chemotherapy and histotripsy treatments, with regular monitoring through scans, biopsies, and blood tests. This trial suits those with colorectal cancer that has spread to the liver and cannot be operated on, and who are undergoing or have just completed chemotherapy. As an unphased trial, it offers a unique opportunity to explore innovative treatment combinations for those seeking new options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants will continue with their chemotherapy treatment as usual. It's best to discuss your specific medications with the trial team.

What prior data suggests that this combination of histotripsy and chemotherapy is safe for treating liver metastases from colorectal cancer?

Research has shown that histotripsy, a non-invasive treatment, is generally well-tolerated for liver tumors. Studies indicate it has few complications overall, with serious ones being rare, suggesting it is safe. The FDA has approved histotripsy for breaking down liver tumors, which supports its safety.

Chemotherapy is a common treatment for many cancers, including colorectal cancer. While it can have side effects, it is widely used, and doctors carefully monitor patients to manage any issues.

Overall, both treatments in this trial have been used safely in other situations. Always consult healthcare providers for personal advice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using histotripsy along with chemotherapy for treating liver metastases from colorectal cancer because it offers a unique, non-invasive approach. While standard treatments typically involve surgery or ablation, histotripsy uses focused ultrasound waves to mechanically disrupt cancer cells without harming surrounding tissues. This could potentially enhance the effectiveness of chemotherapy, making it more targeted and reducing side effects. The combination of these technologies aims to improve patient outcomes by directly attacking tumors in a novel way.

What evidence suggests that histotripsy plus chemotherapy is effective for liver metastases from colorectal cancer?

Research has shown that combining histotripsy with chemotherapy may offer promise for treating liver tumors that have spread from colorectal cancer. Histotripsy, a non-invasive treatment, uses sound waves to break down tumors. Early studies suggest it can control 90% of liver tumors. For patients with liver cancer that has spread, nearly 50% survived for at least one year. In this trial, all participants will receive the combination of histotripsy and chemotherapy. This combination might enhance treatment effectiveness by helping the drugs target the tumors more precisely, potentially extending the time patients live without disease progression. ^{1 3 5 6 7}

Who Is on the Research Team?

Federico Aucejo, MD

Principal Investigator

Cleveland Clinic, Digestive Disease Institute

Are You a Good Fit for This Trial?

This trial is for individuals with advanced colorectal cancer that has spread to the liver and cannot be removed by surgery. Participants must be able to undergo chemotherapy, histotripsy treatments at Cleveland Clinic, CT scans, biopsies of liver lesions, and blood draws. Genetic testing will also be part of their treatment.

Inclusion Criteria

My colorectal cancer has spread to my liver, lungs, or both, but not extensively.

I am starting or already on my first chemotherapy with 5-FU and oxaliplatin or irinotecan.

I have had treatments targeting my liver like ablation or embolization.

Exclusion Criteria

WBC count < 3,000 /uL

Absolute Neutrophil Count < 1,500 /uL

Pregnant participants

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive uninterrupted palliative chemotherapy and histotripsy treatment according to standard procedures

12 weeks

Regular in-person visits for chemotherapy and histotripsy

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiologic assessments and biopsies

90 days

Multiple visits for assessments and biopsies

Long-term Follow-up

Participants are monitored for overall survival and progression-free survival

Up to 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Chemotherapy
• Histotripsy

Trial Overview The study is examining if combining a non-invasive procedure called histotripsy with standard chemotherapy improves progression-free survival in patients with colorectal liver metastasis compared to chemotherapy alone. Histotripsy uses ultrasound energy to destroy tumor tissue.

How Is the Trial Designed?

Group I: Histotripsy + Chemotherapy Experimental Treatment 2 Interventions

All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.

Who Is Running the Clinical Trial?

Case Comprehensive Cancer Center

Lead Sponsor

Trials

472

Recruited

33,400+

HistoSonics, Inc.

Industry Sponsor

Trials

9

Recruited

5,200+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11940794/

The Emerging Role of Histotripsy in Liver Cancer Treatment This poses significant promise in treating tumor metastasis as well as improving clinical regimens by combining histotripsy with immunotherapy.

2. patlynk.com patlynk.com/trial/NCT07044362

Histotripsy and Chemotherapy for Advanced Colorectal ... This study is focused on examining the effectiveness of combining histotripsy, a non-invasive procedure approved by the FDA, with chemotherapy to treat liver ...

3. 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% ... Overall survival at one year was 73.3% for patients with primary liver cancer, and 48.6% in patients with metastatic disease.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07044362

NCT07044362 | Histotripsy Plus Chemotherapy vs ... This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40227626/

Histotripsy of Liver Tumors: Patient Selection, Ethical ... Colorectal cancer alone results in liver metastases in nearly 50% of patients, with approximately 85% presenting with unresectable disease.

7. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.233051

The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy ... Technical success was observed in 42 of 44 treated tumors (95%; 95% CI: 84, 100) and procedure-related major complications were reported in ...