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Recruiting

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

NCT07044362 · Case Comprehensive Cancer Center
In plain English

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Official title
Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
About this study
This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.
Eligibility criteria
Inclusion Criteria: * 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 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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-11-19
Estimated completion: 2028-12-01
Last updated: 2026-09-15
Interventions
Device: HistoSonics Edison® SystemDrug: Chemotherapy
Primary outcomes
  • Radiologic tumor viability (90 days post-treatment)
Sponsor
Case Comprehensive Cancer Center · other
With: HistoSonics, Inc.
Contacts & investigators
ContactFederico Aucejo, MD · contact · Aucejof@ccf.org · 216-445-7159
ContactErlind Allkushi · contact · ALLKUSE2@ccf.org · 216-444-0223
InvestigatorFederico Aucejo, MD · principal_investigator, Cleveland Clinic, Digestive Disease Institute
All locations (1)
Cleveland Clinic, Case Comprehensive Cancer CenterRecruiting
Cleveland, Ohio, United States