Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis (NCT07044362)
Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (12 items).
Location: Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio
📞 Contact the Study Coordinator
Phone: (216) 445-7159
Email: Aucejof@ccf.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.