Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Case Comprehensive Cancer Center
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Cleveland
Source: ClinicalTrials.gov · NCT07044362 · last updated 2026-09-15