RecruitingRecruiting
Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
NCT07044362 · Case Comprehensive Cancer Center
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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