Actively Recruiting
Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
Led by Case Comprehensive Cancer Center · Updated on 2026-03-19
100
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
Sponsors
C
Case Comprehensive Cancer Center
Lead Sponsor
H
HistoSonics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Participants with liver-confined colorectal cancer liver metastasis or low-volume pulmonary disease along with CRLM
- Receiving first-line therapy with 5-FU combined with oxaliplatin or irinotecan, or within 3 months of starting chemotherapy, or completed chemotherapy within 1 month before histotripsy evaluation
- Participants who have undergone other liver-directed therapies such as ablation or embolization
- Participants with multiple unresectable metastases that cannot be fully treated by resection or ablation
You will not qualify if you...
- Participants with resectable disease
- Participants with non-pulmonary extra-hepatic disease including bone or peritoneal metastasis
- Participants unable to tolerate general anesthesia
- Participants with Childs C Cirrhosis
- Participants with another non-skin malignancy within the past 2 years
- White blood cell count less than 3,000 /uL
- Absolute neutrophil count less than 1,500 /uL
- History of serious non-malignant illness increasing histotripsy risk
- Participants with MSI-High
- Participants under 18 years old
- Pregnant participants
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
F
Federico Aucejo, MD
CONTACT
E
Erlind Allkushi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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