RECRUITING

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial

Quick Facts

Study Start:2025-06-30
Study Completion:2028-04-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07044362

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants with liver-confined colorectal cancer liver metastasis (CRLM) or Participants who have low-volume pulmonary disease along with CRLM.
  2. * Participants receiving first line therapy with base of 5-FU with either oxaliplatin or irinotecan, or who are within one month of beginning chemotherapy.
  3. * Participants who have undergone other liver-directed therapy, such as ablation, embolization.
  4. * Participants with bilobar, unresectable metastases that cannot be completely treated with resection and/or ablation.
  5. * Participants aged ≥18 years
  1. * Participants with resectable disease.
  2. * Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.
  3. * Participants who are not able to tolerate general anesthesia.
  4. * Participants who have Childs C Cirrhosis.
  5. * Other non-skin malignancy within 2 years of study.
  6. * WBC count \< 3,000 /uL.
  7. * Absolute Neutrophil Count \< 1,500 /uL.
  8. * History of Non-malignant serious concurrent illness that would increase the risk of histotripsy.
  9. * Participants with BRAF V600E mutated tumors.
  10. * Participants with MSI-High.
  11. * Participants aged \< 18 years
  12. * Pregnant participants

Contacts and Locations

Study Contact

Federico Aucejo, MD
CONTACT
216-445-7159
Aucejof@ccf.org
Erlind Allkushi
CONTACT
216-444-0223
ALLKUSE2@ccf.org

Principal Investigator

Federico Aucejo, MD
PRINCIPAL_INVESTIGATOR
Cleveland Clinic, Digestive Disease Institute

Study Locations (Sites)

Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

  • Federico Aucejo, MD, PRINCIPAL_INVESTIGATOR, Cleveland Clinic, Digestive Disease Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-30
Study Completion Date2028-04-01

Study Record Updates

Study Start Date2025-06-30
Study Completion Date2028-04-01

Terms related to this study

Keywords Provided by Researchers

  • Histotripsy
  • Liver-confined
  • Liver colorectal cancer liver metastasis
  • Liver-confined colorectal cancer liver metastasis
  • Chemotherapy
  • Advanced Colorectal
  • Advanced Colorectal Liver Metastasis

Additional Relevant MeSH Terms

  • Colorectal Cancer
  • Liver Metastases
  • Liver Cancer