Histotripsy plus chemotherapy versus chemotherapy alone for colorectal cancer spread to the liver
Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
This trial will test whether adding noninvasive histotripsy to standard chemotherapy helps people with unresectable, liver‑confined colorectal cancer metastases stay free of disease progression longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT07044362 on ClinicalTrials.gov |
What this trial studies
This prospective interventional trial compares adding noninvasive histotripsy to standard 5‑FU–based chemotherapy versus chemotherapy alone in patients with unresectable colorectal liver metastases. Up to 100 adults with liver‑confined disease (or low‑volume pulmonary disease) will receive routine chemotherapy while selected participants also undergo histotripsy treatments using the HistoSonics Edison® System. Participants will have scheduled CT scans, occasional biopsies of treated and untreated liver lesions, blood draws, and standard-of-care genetic testing during follow-up. The main outcome is progression‑free survival, with additional imaging and safety endpoints recorded.
Who should consider this trial
Good fit: Adults (≥18) with unresectable, bilobar colorectal liver metastases (or low‑volume lung disease) who are starting or recently started standard 5‑FU–based chemotherapy and can tolerate general anesthesia are ideal candidates.
Not a fit: Patients with resectable liver disease, non‑pulmonary extra‑hepatic metastases, or severe cirrhosis (Child‑Pugh C) are unlikely to be eligible and may not benefit from this approach.
Why it matters
Potential benefit: If successful, adding histotripsy could prolong progression‑free survival and improve local control of liver metastases without requiring major surgery.
How similar studies have performed: Histotripsy has FDA De Novo clearance for noninvasive destruction of liver tumors and early work shows it can ablate liver lesions, but combining histotripsy with chemotherapy for colorectal liver metastases is a relatively new strategy.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Federico Aucejo, MD — Cleveland Clinic, Digestive Disease Institute
- Study coordinator: Federico Aucejo, MD
- Email: Aucejof@ccf.org
- Phone: 216-445-7159
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.