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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
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).
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
RECRUITINGRadiologic 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
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