RECRUITING

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

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.

Study Overview

Study Details

Study overview

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.

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

Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Cleveland

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

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

Study Record Dates

2028-04-01