Histotripsy and Chemotherapy for Advanced Colorectal Liver Metastasis Treatment
This clinical trial explores the use of histotripsy and chemotherapy to reduce the viability of advanced colorectal liver metastasis, aiming to improve the treatment for those affected.
HistoSonics Edison® System
+ Chemotherapy
Colonic Diseases+10
+ Digestive System Diseases
+ Digestive System Neoplasms
Supportive Care Study
Summary
Study start date: June 30, 2025
Actual date on which the first participant was enrolled.This study is focused on examining the effectiveness of combining histotripsy, a non-invasive procedure approved by the FDA, with chemotherapy to treat liver tumors in patients who have colorectal cancer that has spread to the liver. Histotripsy uses sound waves to break down liver tumors without the need for surgery. The trial aims to include up to 100 participants who have colorectal cancer that has metastasized, or spread, to the liver. The goal is to see if this combination can offer better treatment outcomes for these patients, potentially providing a new option for those affected by this condition. Participants in this study will receive both histotripsy and chemotherapy to target their liver tumors. The study will closely monitor the effects of this combined treatment on the liver tumors, assessing how well the tumors are reduced or eliminated. While the study aims to determine the benefits of this approach, as with any medical procedure, there may be risks involved. The study will not only look at the effectiveness but also monitor any side effects or complications that may arise from the treatment combination.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.100 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location