RecruitingNot ApplicableNCT07044362

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial


Sponsor

Case Comprehensive Cancer Center

Enrollment

100 participants

Start Date

Jun 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if histotripsy plus chemotherapy works to treat unresectable, bilobar liver- confined colorectal cancer liver metastasis (CRLM). The main question this clinical trial aims to answer is: • Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival? Participants will: * Receive chemotherapy treatment per standard procedure. * Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic. * Occasionally receive Computerized Tomography (CT) scan with and without contrast, give biopsy of treated and untreated liver lesions, and participate in a blood draw of up to 3 teaspoons at each in-person visit. * Participate in genetic testing, as a part of the standard of care for the treatment.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding histotripsy — a non-invasive technique that uses focused ultrasound waves to physically destroy tumors — to standard chemotherapy improves outcomes for patients with colorectal cancer that has spread to the liver. The ultrasound waves break apart tumor tissue without surgery or radiation. **You may be eligible if...** - You have colorectal cancer liver metastases (cancer that has spread from the colon or rectum to the liver) - You have multiple liver tumors that cannot be completely removed by surgery - You are currently on or about to start first-line chemotherapy (5-FU based) - You may also have a small amount of disease in the lungs - You may have previously had other liver-directed treatments (such as ablation or embolization) **You may NOT be eligible if...** - Your liver tumors can be completely removed with surgery - You are not eligible for or not receiving chemotherapy - You have extensive disease outside the liver that would affect outcomes - Your overall health does not allow the procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEHistoSonics Edison® System

Histotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.

DRUGChemotherapy

Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).


Locations(1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07044362


Related Trials