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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
