[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596354":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":32,"locations":41,"responsibleParty":58,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":21,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":21,"enrollmentInfo":73,"targetDuration":21,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":44,"whyStopped":21,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Case Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Histotripsy + Chemotherapy","EXPERIMENTAL","All enrolled participants will undergo combined treatment with Histotripsy and chemotherapy without interruption in the chemotherapy.",[13,14],"Device: HistoSonics Edison® System","Drug: Chemotherapy",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","HistoSonics Edison® System","Histotripsy is a novel, totally non-invasive, non-ionizing, and non-thermal ablation technique that mechanically disrupts tumors through precisely controlled acoustic cavitation. Histotripsy is administered via HistoSonics Edison® System.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"DRUG","Chemotherapy","Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).",[9],[28],{"name":29,"affiliation":30,"role":31},"Federico Aucejo, MD","Cleveland Clinic, Digestive Disease Institute","PRINCIPAL_INVESTIGATOR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":21,"email":36},"CONTACT","216-445-7159","Aucejof@ccf.org",{"name":38,"role":34,"phone":39,"phoneExt":21,"email":40},"Erlind Allkushi","216-444-0223","ALLKUSE2@ccf.org",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Cleveland Clinic, Case Comprehensive Cancer Center","RECRUITING","Cleveland","Ohio","44195","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-81.69541,41.4995,{"lat":54,"lon":53},[57],{"name":29,"role":34,"phone":21,"phoneExt":21,"email":21},{"type":59,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR",[61],{"name":62,"class":63},"HistoSonics, Inc.","INDUSTRY","100596354","histotripsy-plus-chemotherapy-vs-chemotherapy-alone-for-advanced-colorectal-liver-metastasis-100596354",false,"NCT07044362","Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis","Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial","Inclusion Criteria:\n\n* Participants with liver-confined colorectal cancer liver metastasis (CRLM) or participants who have low-volume pulmonary disease along with CRLM\n* 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\n* Participants who have undergone other liver-directed therapy, such as ablation, embolization\n* Participants with multiple unresectable metastases that cannot be completely treated with resection and\u002For ablation\n* Participants aged ≥18 years\n\nExclusion Criteria:\n\n* Participants with resectable disease\n* Participants with non-pulmonary extra-hepatic disease including but not limited to bone or peritoneal metastasis.\n* Participants who are not able to tolerate general anesthesia\n* Participants who have Childs C Cirrhosis\n* Other non-skin malignancy within 2 years of study\n* WBC count \\\u003C 3,000 \u002FuL\n* Absolute Neutrophil Count \\\u003C 1,500 \u002FuL\n* History of Non-malignant serious concurrent illness that would increase the risk of histotripsy\n* Participants with MSI-High\n* Participants aged \\\u003C 18 years\n* Pregnant participants","ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","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:\n\n• Does the management of this condition with uninterrupted palliative chemotherapy and histotripsy demonstrate improved progression-free survival?\n\nParticipants will:\n\n* Receive chemotherapy treatment per standard procedure.\n* Undergo histotripsy treatment according to current standard procedures at Cleveland Clinic.\n* 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.\n* Participate in genetic testing, as a part of the standard of care for the treatment.",[81,82,83],"Colorectal Cancer","Liver Metastases","Liver Cancer",[85,86,87,88,24,89,90],"Histotripsy","Liver-confined","Liver colorectal cancer liver metastasis","Liver-confined colorectal cancer liver metastasis","Advanced Colorectal","Advanced Colorectal Liver Metastasis","2026-03-18",{"date":93,"type":94},"2026-03-19","ACTUAL",{"date":96,"type":94},"2025-06-30",{"date":98,"type":75},"2028-10-01",{"name":5,"class":6},1]