Overview
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.
Description
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
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