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Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

NCT07044362 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

HistoSonics 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.

DRUG

Chemotherapy

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

Sponsors & Collaborators

  • HistoSonics, Inc.

    collaborator INDUSTRY

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Federico Aucejo, MD · Cleveland Clinic, Digestive Disease Institute

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2026-10-01
Completion
2028-10-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07044362 on ClinicalTrials.gov