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Histotripsy and Chemotherapy for Advanced Colorectal Liver Metastasis Treatment

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Study AimThis clinical trial explores the use of histotripsy and chemotherapy to reduce the viability of advanced colorectal liver metastasis, aiming to improve the treatment for those affected.
What is being tested

HistoSonics Edison® System

+ Chemotherapy
Device
Drug
Who is being recruted

Colonic Diseases
+10

+ Digestive System Diseases
+ Digestive System Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorCase Comprehensive Cancer Center
Study ContactFederico Aucejo, MDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: June 30, 2025Actual date on which the first participant was enrolled.

This study is focused on examining the effectiveness of combining histotripsy, a non-invasive procedure approved by the FDA, with chemotherapy to treat liver tumors in patients who have colorectal cancer that has spread to the liver. Histotripsy uses sound waves to break down liver tumors without the need for surgery. The trial aims to include up to 100 participants who have colorectal cancer that has metastasized, or spread, to the liver. The goal is to see if this combination can offer better treatment outcomes for these patients, potentially providing a new option for those affected by this condition. Participants in this study will receive both histotripsy and chemotherapy to target their liver tumors. The study will closely monitor the effects of this combined treatment on the liver tumors, assessing how well the tumors are reduced or eliminated. While the study aims to determine the benefits of this approach, as with any medical procedure, there may be risks involved. The study will not only look at the effectiveness but also monitor any side effects or complications that may arise from the treatment combination.

Official TitleHistotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial 
NCT07044362
Principal SponsorCase Comprehensive Cancer Center
Study ContactFederico Aucejo, MDMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
100 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Colorectal Neoplasms
Criteria

Inclusion Criteria: * Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM * Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within 3 months of beginning chemotherapy, or participants who have completed chemotherapy treatment within 1 month of the histotripsy evaluation * Participants who have undergone other liver-directed therapy, such as ablation, embolization * Participants with multiple unresectable metastases that cannot be completely treated with resection and/or ablation * Participants aged ≥18 years Exclusion Criteria: * Participants with resectable disease * Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis. * Participants who are not able to tolerate general anesthesia * Participants who have Childs C Cirrhosis * Other non-skin malignancy within 2 years of study * WBC count \< 3,000 /uL * Absolute Neutrophil Count \< 1,500 /uL * History of Non-malignant serious concurrent illness that would increase the risk of histotripsy * Participants with MSI-High * Participants aged \< 18 years * Pregnant participants

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.

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.

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

As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)
Secondary Objectives

The safety profile of the treatment, as measured by the complications at 30 days.

The safety profile of the treatment, as measured by the complications at 90 days.

Biopsy results will be used to assess the infiltration of CTLA-4.

Median overall survival will be measured up to 2 years post treatment.

The rate of progression free survival will be measured up to 2 years post treatment.

Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.

Biopsy results will be used to assess the percentage of lesions that have viable tumor.

Biopsy results will be used to assess the infiltration of CD4.

Biopsy results will be used to assess the infiltration of CD8.

Biopsy results will be used to assess the infiltration of B-cells.

Biopsy results will be used to assess the infiltration of CD45.

Biopsy results will be used to assess the infiltration of CD68.

Biopsy results will be used to assess the infiltration of PD-1.

Biopsy results will be used to assess the infiltration of PD-L1.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Cleveland Clinic, Case Comprehensive Cancer CenterCleveland, United StatesSee the location
Recruiting
One Study Center
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