Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
Recruiting · NCT07044362 · Interventional (participants receive a specific treatment) · Lead sponsor: Case Comprehensive Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed across 1 US state.
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland, Ohio, United States