[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07044362":3,"trial-entities:NCT07044362":156,"trial-summary:NCT07044362":161},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":48,"secondary_outcomes":53,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":125,"locations":128,"central_contacts":142,"overall_officials":150,"references":154,"see_also_links":155},"NCT07044362","CASE6224","Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis","Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis: A Prospective, Single-Armed Trial","RECRUITING","2028-10-01","2026-03","2026-03-19","2025-06-30","Case Comprehensive Cancer Center","OTHER",true,"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.","This is a prospective trial testing the benefits of histotripsy plus chemotherapy for participants with colorectal liver metastasis. Histotripsy has been approved by the FDA with De Novo classification for non-invasive destruction of liver tumors. Up to 100 participants with colorectal cancer liver metastasis will be included.",[19,20,21],"Colorectal Cancer","Liver Metastases","Liver Cancer",[23,24,25,26,27,28,29],"Histotripsy","Liver-confined","Liver colorectal cancer liver metastasis","Liver-confined colorectal cancer liver metastasis","Chemotherapy","Advanced Colorectal","Advanced Colorectal Liver Metastasis","INTERVENTIONAL","SUPPORTIVE_CARE",[33],"NA",{"count":35,"type":36},100,"ESTIMATED",[38,44],{"type":39,"name":40,"description":41,"armGroupLabels":42},"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.",[43],"Histotripsy + Chemotherapy",{"type":45,"name":27,"description":46,"armGroupLabels":47},"DRUG","Chemotherapy (standard of care with first line therapy of base of 5-FU with either oxaliplatin or irinotecan).",[43],[49],{"measure":50,"description":51,"timeFrame":52},"Radiologic tumor viability","As assessed by the degree of short-term local tumor control in Colorectal Liver Metastasis(CRLM)","90 days post-treatment",[54,58,61,64,68,72,75,78,81,85,88,92,95,98],{"measure":55,"description":56,"timeFrame":57},"Rate of Tumor Necrosis","Biopsy results will be used to assess the degree of tumor necrosis in treated lesions.","30 days post-treatment",{"measure":59,"description":60,"timeFrame":57},"Percentage of Viable Tumor in Lesion","Biopsy results will be used to assess the percentage of lesions that have viable tumor.",{"measure":62,"description":63,"timeFrame":57},"Infiltration of CD4","Biopsy results will be used to assess the infiltration of CD4.",{"measure":65,"description":66,"timeFrame":67},"Infiltration of CD8","Biopsy results will be used to assess the infiltration of CD8.","Baseline, 30 days post-treatment",{"measure":69,"description":70,"timeFrame":71},"Infiltration of B-cells","Biopsy results will be used to assess the infiltration of B-cells.","30 days post- treatment",{"measure":73,"description":74,"timeFrame":57},"Infiltration of CD45","Biopsy results will be used to assess the infiltration of CD45.",{"measure":76,"description":77,"timeFrame":57},"Infiltration of CD68","Biopsy results will be used to assess the infiltration of CD68.",{"measure":79,"description":80,"timeFrame":57},"Infiltration of PD-1","Biopsy results will be used to assess the infiltration of PD-1.",{"measure":82,"description":83,"timeFrame":84},"Infiltration of PD-L1","Biopsy results will be used to assess the infiltration of PD-L1.","30 days after treatment",{"measure":86,"description":87,"timeFrame":57},"Infiltration of CTLA-4","Biopsy results will be used to assess the infiltration of CTLA-4.",{"measure":89,"description":90,"timeFrame":91},"Overall Survival","Median overall survival will be measured up to 2 years post treatment.","Up to 24 months post-treatment",{"measure":93,"description":94,"timeFrame":91},"Progression Free Survival (PFS)","The rate of progression free survival will be measured up to 2 years post treatment.",{"measure":96,"description":97,"timeFrame":57},"30 day Complications","The safety profile of the treatment, as measured by the complications at 30 days.",{"measure":99,"description":100,"timeFrame":52},"90 day Complications","The safety profile of the treatment, as measured by the complications at 90 days.","ALL","18 Years",null,false,{"inclusion":106,"exclusion":112,"raw_text":124},[107,108,109,110,111],"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\u002For ablation","Participants aged ≥18 years",[113,114,115,116,117,118,119,120,121,122,123],"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 \\\u003C 3,000 \u002FuL","Absolute Neutrophil Count \\\u003C 1,500 \u002FuL","History of Non-malignant serious concurrent illness that would increase the risk of histotripsy","Participants with MSI-High","Participants aged \\\u003C 18 years","Pregnant participants","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",[126,127],"ADULT","OLDER_ADULT",[129],{"facility":130,"status":8,"city":131,"state":132,"zip":133,"country":134,"contacts":135,"geoPoint":139},"Cleveland Clinic, Case Comprehensive Cancer Center","Cleveland","Ohio","44195","United States",[136],{"name":137,"role":138},"Federico Aucejo, MD","CONTACT",{"lat":140,"lon":141},41.4995,-81.69541,[143,146],{"name":137,"role":138,"phone":144,"email":145},"216-445-7159","Aucejof@ccf.org",{"name":147,"role":138,"phone":148,"email":149},"Erlind Allkushi","216-444-0223","ALLKUSE2@ccf.org",[151],{"name":137,"affiliation":152,"role":153},"Cleveland Clinic, Digestive Disease Institute","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":157,"biomarkers":160},[158,159],"Colorectal Carcinoma","Metastatic Malignant Neoplasm in the Liver",[],{"nct_id":4,"found":15,"summary":162,"prompt_version":172},{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This is a study testing the benefits of histotripsy plus chemotherapy. Up to 100 participants with colorectal cancer liver metastasis will be included.","completed","Histotripsy Plus Chemotherapy for Advanced Colorectal Liver Metastasis","This study is looking at whether adding histotripsy to standard chemotherapy can help people with advanced colorectal cancer that has spread to the liver (colorectal liver metastasis). Histotripsy uses sound waves to mechanically break down tumors without surgery or heat. You might be able to join if you have colorectal cancer that has spread to your liver, or to your liver and a small amount to your lungs. You should also be receiving certain chemotherapy treatments (5-FU with oxaliplatin or irinotecan), or have recently started or finished them. The study wants to see if this combination improves how long you live without your cancer getting worse. The study is currently unclear on its recruitment status and plans to enroll up to 100 participants.","The study measures tumor viability at 90 days after treatment.",123,"You will receive standard chemotherapy and histotripsy treatment. You will also have occasional CT scans, biopsies of liver lesions, and blood draws at in-person visits.","Not stated in the trial record.",[27],"v2"]