An interventional study of HistoSonics Edison® System and Chemotherapy in Colorectal Cancer, Liver Metastases and Liver Cancer, sponsored by Case Comprehensive Cancer Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Supportive care
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:
Participants will:
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 100 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.
Device: HistoSonics Edison® System · Drug: Chemotherapy
Histotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.
Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).
Radiologic tumor viability
As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)
Time frame: 90 days post-treatment
Rate of Tumor Necrosis
Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.
Time frame: 30 days post-treatment
Percentage of Viable Tumor in Lesion
Biopsy results will be used to assess the percentage of lesions that have viable tumor.
Time frame: 30 days post-treatment
Infiltration of CD4
Biopsy results will be used to assess the infiltration of CD4.
Time frame: 30 days post-treatment
Infiltration of CD8
Biopsy results will be used to assess the infiltration of CD8.
Time frame: Baseline, 30 days post-treatment
Infiltration of B-cells
Biopsy results will be used to assess the infiltration of B-cells.
Time frame: 30 days post- treatment
Infiltration of CD45
Biopsy results will be used to assess the infiltration of CD45.
Time frame: 30 days post-treatment
Infiltration of CD68
Biopsy results will be used to assess the infiltration of CD68.
Time frame: 30 days post-treatment
Infiltration of PD-1
Biopsy results will be used to assess the infiltration of PD-1.
Time frame: 30 days post-treatment
Infiltration of PD-L1
Biopsy results will be used to assess the infiltration of PD-L1.
Time frame: 30 days after treatment
Infiltration of CTLA-4
Biopsy results will be used to assess the infiltration of CTLA-4.
Time frame: 30 days post-treatment
Overall Survival
Median overall survival will be measured up to 2 years post treatment.
Time frame: Up to 24 months post-treatment
Progression Free Survival (PFS)
The rate of progression free survival will be measured up to 2 years post treatment.
Time frame: Up to 24 months post-treatment
30 day Complications
The safety profile of the treatment, as measured by the complications at 30 days.
Time frame: 30 days post-treatment
90 day Complications
The safety profile of the treatment, as measured by the complications at 90 days.
Time frame: 90 days post-treatment
Plan to share: No — There is no need for sharing IPD for this clinical trial.
No publications or documents are linked to this record.
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