Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Launched by CASE COMPREHENSIVE CANCER CENTER · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to treat advanced colorectal cancer that has spread to the liver but cannot be removed by surgery. Researchers want to find out if combining a treatment called histotripsy—a non-invasive procedure that uses focused ultrasound waves to break up tumors—with standard chemotherapy can help patients live longer without their cancer getting worse, compared to chemotherapy alone.

People who might be eligible for this study are adults with colorectal cancer that has spread mainly to both sides of the liver and cannot be fully removed or treated with other local methods. Some patients with small lung involvement may also qualify. Participants will receive chemotherapy as usual and will also undergo histotripsy treatment at the Cleveland Clinic. They may have CT scans, biopsies (tissue samples), blood tests, and genetic testing during their visits. The study is not open for enrollment yet, and certain health conditions or types of cancer mutations may exclude some patients. Overall, this trial aims to offer a new option to improve care for patients with difficult-to-treat liver metastases from colorectal cancer.

Gender

ALL

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 one month of beginning chemotherapy.
• • Participants who have undergone other liver-directed therapy, such as ablation, embolization.
• • Participants with bilobar, 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 BRAF V600E mutated tumors.
• • Participants with MSI-High.
• • Participants aged \< 18 years
• • Pregnant participants