Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares histotripsy plus chemotherapy with chemotherapy alone. It is for adults whose colon or rectal cancer has spread to the liver and cannot be fully removed or treated; some people with a small amount of cancer in the lungs may also qualify. The study tests whether adding histotripsy helps people live longer without their cancer getting worse.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have colon or rectal cancer that has spread only to the liver, or to the liver with a small amount in the lungs.
- Receive first-choice chemotherapy with 5-FU plus oxaliplatin or irinotecan; have started chemotherapy within 3 months; or have finished chemotherapy within 1 month before the histotripsy evaluation.
- Have had other liver treatments, such as ablation (destroying tumors) or embolization (blocking their blood supply).
- Have several tumors that cannot all be removed by surgery or destroyed with ablation.
- Be age 18 or older.
Who can't join
- Cancer can be removed by surgery.
- Cancer has spread outside the liver to places other than the lungs, such as bones or the lining of the belly.
- Cannot safely receive medicine that keeps you asleep during treatment, or have another serious illness that raises the risks of histotripsy.
- Have Child-Pugh class C cirrhosis, a severe form of liver scarring.
- Have had another cancer, other than skin cancer, within 2 years of the study.
- Have a white blood cell count below 3,000 per microliter or a neutrophil count below 1,500 per microliter. These cells help fight infection.
- Have MSI-high cancer, which has many changes in certain repeated parts of its DNA.
- Are under age 18 or pregnant.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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 sites (1)
OH
- Cleveland Clinic, Case Comprehensive Cancer Center · Cleveland, OH 44195Federico Aucejo, MD · Study contactMore trials in Cleveland