Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis

This study is looking at whether adding histotripsy to standard chemotherapy can help people with advanced colorectal cancer that has spread to the liver (colorectal liver metastasis). Histotripsy uses sound waves to mechanically break down tumors without surgery or heat. You might be able to join if you have colorectal cancer that has spread to your liver, or to your liver and a small amount to your lungs. You should also be receiving certain chemotherapy treatments (5-FU with oxaliplatin or irinotecan), or have recently started or finished them. The study wants to see if this combination improves how long you live without your cancer getting worse. The study is currently unclear on its recruitment status and plans to enroll up to 100 participants.

Study design
This is a study testing the benefits of histotripsy plus chemotherapy. Up to 100 participants with colorectal cancer liver metastasis will be included.
What's involved
You will receive standard chemotherapy and histotripsy treatment. You will also have occasional CT scans, biopsies of liver lesions, and blood draws at in-person visits.
Compensation
Not stated in the trial record.
Follow-up
The study measures tumor viability at 90 days after treatment.

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NCT07044362

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Recruiting
NAAges 18+InterventionalSupportive care
Case Comprehensive Cancer Center
~100 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:HistoSonics Edison® SystemChemotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiologic tumor viability
Measured over 90 days post-treatment
Colorectal Cancer
Liver Metastases
Liver Cancer
1 sites across 1 states
Ohio1
  • Federico Aucejo, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic, Digestive Disease Institute

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Radiologic tumor viability90 days post-treatment

    As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)