Histotripsy plus chemotherapy versus chemotherapy alone for colorectal cancer spread to the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Integrated genomic and clinical database for cancer biomarker discovery

  Researchers are building a combined genomic and clinical database at Samsung Medical Center to test biomarkers for cancer diagnosis, treatment choice, and predicting how well treatments work.

  Recruiting Samsung Medical Center · Seoul, Gang-Nam · NCT07911267

• Prospective look at liver metastases imaging and tissue patterns in colorectal and breast cancer

  This observational study tests whether 3D maps of histopathological growth patterns in liver metastases align with imaging features from MRI/CT in patients undergoing liver surgery.

  Recruiting Cancer Research Antwerp · Wilrijk, Antwerp · NCT07781306

• DRAGON: International registry for patients who had combined portal and hepatic vein embolization before liver surgery

  This registry collects data on patients who had PVE/HVE before liver resection to see if it helps liver regeneration and what factors relate to outcomes.

  Recruiting at 30 sites Maastricht University Medical Center · Chicago, Illinois and 30 other locations · NCT07717437

• Precision navigation to boost cancer screening participation in high-risk communities

  This study tests whether a personalized navigation program helps adults aged 45–74 in Chinese communities who are at high risk for several cancers to complete recommended free cancer screenings.

  Recruiting at 3 sites Hunan Cancer Hospital · Huaihua, Hunan and 2 other locations · NCT07676383

• Metastatic liver cancer patient registry from multiple Chinese centers

  This is a registry that collects real-world data on adults with liver metastases to understand patterns and prognosis and to support future research.

  Recruiting at 2 sites Anhui Provincial Hospital · Bengbu, Anhui and 2 other locations · NCT07602504

• AI language tools to help tumor care teams write MDT reports

  We will test whether AI language tools can help junior cancer doctors write MDT diagnosis and treatment reports more accurately and faster.

  Recruiting at 2 sites Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong and 1 other locations · NCT07504367

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.