[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571812":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":38,"centralContacts":42,"locations":48,"responsibleParty":82,"collaborators":37,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":37,"studyType":99,"phases":100,"briefSummary":103,"conditions":104,"keywords":109,"overallStatus":72,"whyStopped":37,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"University Health Network, Toronto","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Treatment","This is a pilot, single-arm study enrolling 48 patients to evaluate the feasibility of locoregional therapy followed by immunotherapy in patients with advanced liver cancer. Patients will receive stereotactic body radiotherapy or Yttrium-90 radioembolization as per the standard-of-care (SOC) protocol, determined during Multidisciplinary Rounds.\n\nStarting two to six weeks after radiotherapy, patients will begin treatment with Atezolizumab and Bevacizumab administered in approximately 21-day intervals, following SOC procedures, for a maximum of 9 months. Clinical follow-up will align with SOC protocols, and imaging will be performed every 2-3 months during immunotherapy.\n\nIf a patient is sufficiently responding to treatment at any follow-up, patients will be referred for transplant evaluation and added to the waitlist if no contraindications are found. Patients with disease progression or who become ineligible for LT due to other factors will be transitioned off the study.",[12,13,14],"Biological: Atezolizumab & Bevacizumab","Drug: Yttrium-90 (Y-90)","Radiation: Stereotactic body radiotherapy (SBRT)",[16,25,32],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Atezolizumab & Bevacizumab","Atezolizumab \\& Bevacizumab will be initiated as part of the study, as per standard treatment protocol. Administration of Atezolizumab and Bevacizumab will be performed according to SOC in approx. 21-days intervals. Clinical follow up during treatment will be done as per SOC in medical and surgical oncology clinics at UHN.",[9],[22,23,24],"AtezoBev","AVASTIN","TECENTRIQ",{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Yttrium-90 (Y-90)","Storage, administration and treatment of Y90-RE will be done according to established treatment protocols and standard of care at UHN.",[9],[31],"YTTRIGA",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"RADIATION","Stereotactic body radiotherapy (SBRT)","Dose and administration frequency of SBRT will be done as per current standards for treating HCC at UHN.",[9],null,[39],{"name":40,"affiliation":5,"role":41},"Gonzalo Sapisochin, MD, PhD, MSc","PRINCIPAL_INVESTIGATOR",[43],{"name":44,"role":45,"phone":46,"phoneExt":37,"email":47},"Clinical Research Manager","CONTACT","437-772-4354","roxana.bucur@uhn.ca",[49,70],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"London Health Sciences Centre","NOT_YET_RECRUITING","London","Ontario","N6A 5A5","Canada","CA",{"type":58,"coordinates":59},"Point",[60,61],-81.23304,42.98339,{"lat":61,"lon":60},[64,68],{"name":44,"role":45,"phone":65,"phoneExt":66,"email":67},"519-685-8500","37517","crystal.engelage@lhsc.on.ca",{"name":69,"role":45,"phone":37,"phoneExt":37,"email":37},"Surgical Director of Liver Transplantation, MD, PhD",{"facility":71,"status":72,"city":73,"state":53,"zip":74,"country":55,"countryCode":56,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"Toronto General Hospital","RECRUITING","Toronto","M5G 2C4",{"type":58,"coordinates":76},[77,78],-79.39864,43.70643,{"lat":78,"lon":77},[81],{"name":44,"role":45,"phone":46,"phoneExt":37,"email":47},{"type":41,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":37,"oldOrganization":37},"Gonzalo Sapisochin","LeGresley Chair in Transplant Oncology at UHN, Associate Professor of Surgery Abdominal Transplant & HPB Surgical Oncology","100571812","phase-1-using-radiotherapy-and-immunotherapy-to-treat-advanced-liver-cancer-before-transplant-100571812",false,"NCT06725121","Using Radiotherapy and Immunotherapy to Treat Advanced Liver Cancer Before Transplant","Downstaging of Hepatocellular Carcinoma with Macrovascular Invasion by Radiotherapy (SBRT or Y90) and Atezolizumab Plus Bevacizumab Followed by Liver Transplantation - a Prospective Trial","MacroTrans","Inclusion Criteria:\n\n* Age 18-70\n* Weight \\> 30 kg\n* Child Pugh Turcotte score A5 to B7\n* Macrovascular invasion (Vp1-3)\n* Total tumour volume \\\u003C 350 cm3\n* Alpha Fetoprotein \\\u003C 5000 ng\u002FmL\n* No extrahepatic disease\n* No other contraindications to undergo a LT\n* Eastern Cooperative Oncology Group (ECOG) score 0-1\n* Capable to provide inform consent\n* Radiological and histological confirmation of hepatocellular carcinoma\n\nExclusion Criteria:\n\n* Poorly differentiated HCC\n* Prior therapy for hepatocellular carcinoma other than liver resection or ablation\n* Portal vein tumor thrombus extending beyond main portal vein\n* Obesity class III (BMI ≥ 40 kg\u002Fm2)\n* Contraindications for radiotherapy (Y90 or SBRT) or AtezoBev","ALL","18 Years","70 Years",{"count":97,"type":98},48,"ESTIMATED","INTERVENTIONAL",[101,102],"PHASE1","PHASE2","The goal of this clinical trial is to learn if locoregional therapy and immunotherapy can be used together to help patients with hepatocellular carcinoma (HCC) and macrovascular invasion achieve liver transplantation.\n\nThe main questions it aims to answer are:\n\n* How many patients will achieve transplant with this treatment strategy?\n* What will the 5-year survival and recurrence-free survival rates be for these patients?\n\nParticipants will:\n\n* Undergo a biopsy of the tumor.\n* Receive locoregional therapy (SBRT or Y90) followed by immunotherapy (atezolizumab and bevacizumab) 2 to 6 weeks later, for a maximum of 9 months.\n* Be referred for a liver transplant and undergo the procedure if deemed eligible and safe.\n* If applicable, be followed for five years post-transplant with regular data collection.",[105,106,107,108],"Hepatocellular Carcinoma (HCC)","Macrovascular Invasion","Liver Transplant Surgery","Downstaging",[110,111,112,113,114,115,116,117,118,119,120,121],"SBRT","Y-90","Yittrium-90","Atezolizumab","Bevacizumab","Advanced liver cancer","Radiotherapy","Immunotherapy","Liver cancer","Stereotactic body radiotherapy","Transplant","Liver Transplantation","2024-12-11",{"date":124,"type":125},"2024-12-16","ACTUAL",{"date":127,"type":98},"2024-12",{"date":129,"type":98},"2034-06",{"name":5,"class":6},2]