Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT07044362
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 30, 2025
Status verified
Mar 2026
Primary completion
Oct 1, 2026
Completion
Oct 1, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Histotripsy + Chemotherapy
    All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.

Primary Outcome Measure

Radiologic tumor viability [ Time Frame: 90 days post-treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland Clinic, Case Comprehensive Cancer CenterClevelandOhio44195
Federico Aucejo, MD

Find similar trials in Cleveland, OH

By condition
Colorectal cancerLiver cancer
By specialty
OncologyGI oncologyHepatology
By research site
Cleveland Clinic, Case Comprehensive Cancer Center· Cleveland, OH

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