Histotripsy Plus Chemotherapy vs Chemotherapy Alone for A... | NCT07044362

Studies
Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

NCT07044362

Sponsor

Case Comprehensive Cancer Center

Status

Recruiting

Last Update Posted

Mar 19, 2026Actual

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Colorectal Cancer
Liver Metastases
Liver Cancer

Interventions

HistoSonics Edison® System
Chemotherapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2025Actual

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Oct 1, 2028Estimated

First Submitted Date

Jun 23, 2025

First Submission Date that Met QC Criteria

Jun 23, 2025

First Posted Date

Jun 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2026

Last Update Posted Date

Mar 19, 2026Actual

Name	Class
HistoSonics, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Histotripsy + Chemotherapy	Experimental	All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.	Device: HistoSonics Edison® System Drug: Chemotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HistoSonics Edison® System	Device	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiologic tumor viability	As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)	90 days post-treatment

Secondary Outcomes

Measure	Description	Time Frame
Rate of Tumor Necrosis	Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.	30 days post-treatment
Percentage of Viable Tumor in Lesion	Biopsy results will be used to assess the percentage of lesions that have viable tumor.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Federico Aucejo, MD	Contact	216-445-7159		Aucejof@ccf.org
Erlind Allkushi	Contact	216-444-0223		ALLKUSE2@ccf.org

Overall Officials

Name	Affiliation	Role
Federico Aucejo, MD	Cleveland Clinic, Digestive Disease Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cleveland Clinic, Case Comprehensive Cancer Center	Recruiting	Cleveland	Ohio	44195	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

There is no need for sharing IPD for this clinical trial.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D008113	Liver Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided