[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611335":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":49,"overallOfficials":33,"centralContacts":64,"locations":74,"responsibleParty":134,"collaborators":33,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":138,"sex":144,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":33,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":77,"whyStopped":33,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},{"fullName":5,"class":6},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Pathologic Complete Response (pCR) Rate","pCR rate is defined as the proportion of participants with an absence of residual tumor at the time of surgery, as assessed by central pathological review.","At the time of surgery",[14,17,21,25,29],{"measure":15,"description":16,"timeFrame":12},"Major Pathologic Response (MPR) Rate","MPR rate is defined as the proportion of participants with =\\\u003C30% residual viable tumor in the tumor bed at the time of surgery, as assessed by central pathological review.",{"measure":18,"description":19,"timeFrame":20},"Relapse-Free Survival (RFS)","RFS is defined as the time from surgery to the first documented recurrence of disease (intrahepatic or extrahepatic) according to EASL and\u002For RECIST v1.1, or death from any cause.","Surgery to the first documented recurrence of disease (up to approximately 2 years)",{"measure":22,"description":23,"timeFrame":24},"Event-Free Survival (EFS)","EFS is defined as the time from enrollment to any of the following events (whichever occurs first): disease progression that precludes surgery, as assessed by the investigator according RECIST v1.1; local regional, or distant disease recurrence as measured by EASL and\u002For RECIST v1.1; or death from any cause.","Enrollment up to approximately 2 years",{"measure":26,"description":27,"timeFrame":28},"Overall Survival (OS)","OS is defined as the time from enrollment to death from any cause.","Enrollment to death from any cause (up to approximately 5 years)",{"measure":30,"description":31,"timeFrame":32},"Treatment-related and -unrelated toxicities (AEs, SAEs) according to NCI CTCAE v5.0","Summary of adverse events by treatment arm and CTCAE (version 5.0) grade and frequency of clinically significant abnormal laboratory parameters.","From the start of treatment to 30 days after surgery",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","TREATMENT",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Atezolizumab + Bevacizumab + TACE","EXPERIMENTAL","Participants will receive Atezolizumab plus Bevacizumab on Day 1 of a 21-Day cycle, total 5 cycles( Atezolizumab plus Bevacizumab were used in combination for 4 cycles, and Bevacizumab was discontinued in cycle 5. ), after perform 2-3 transarterial chemoembolization procedure on-demand.",[46,47,48],"Drug: Atezolizumab","Drug: Bevacizumab","Procedure: Transarterial chemoembolization (TACE)",[50,55,59],{"type":51,"name":52,"description":53,"armGroupLabels":54,"otherNames":33},"DRUG","Atezolizumab","Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.",[42],{"type":51,"name":56,"description":57,"armGroupLabels":58,"otherNames":33},"Bevacizumab","Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg\u002Fkg on Day 1 of each 21-day Cycle.",[42],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":33},"PROCEDURE","Transarterial chemoembolization (TACE)","TACE will be performed by clinical demand.",[42],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":33,"email":69},"Xinyu Bi","CONTACT","+86 (010)87787100","beexy1971@163.com",{"name":71,"role":67,"phone":72,"phoneExt":33,"email":73},"Xiaowu Zhang","+86 (010)87788502","zhangxiaowu767@163.com",[75,91,106,120],{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"Cancer Hospital Chinese Academy of Medical Science","RECRUITING","Beijing","Beijing Municipality","100021","China","CN",{"type":84,"coordinates":85},"Point",[86,87],116.39723,39.9075,{"lat":87,"lon":86},[90],{"name":66,"role":67,"phone":68,"phoneExt":33,"email":69},{"facility":92,"status":93,"city":94,"state":95,"zip":33,"country":81,"countryCode":82,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Henan Cancer Hospital","NOT_YET_RECRUITING","Zhengzhou","Henan",{"type":84,"coordinates":97},[98,99],113.64861,34.75778,{"lat":99,"lon":98},[102],{"name":103,"role":67,"phone":104,"phoneExt":33,"email":105},"Jinxue Zhou","+86(0371)65587787","zhoujx888@126.com",{"facility":107,"status":93,"city":108,"state":109,"zip":33,"country":81,"countryCode":82,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"The First Hospital of China Medical University","Shenyang","Liaoning",{"type":84,"coordinates":111},[112,113],123.43278,41.79222,{"lat":113,"lon":112},[116],{"name":117,"role":67,"phone":118,"phoneExt":33,"email":119},"Gang Wu","+86(024)83283308","cmuwgzwl@126.com",{"facility":121,"status":93,"city":122,"state":123,"zip":33,"country":81,"countryCode":82,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Shanxi Cancer Hospital","Taiyuan","Shanxi",{"type":84,"coordinates":125},[126,127],112.56028,37.86944,{"lat":127,"lon":126},[130],{"name":131,"role":67,"phone":132,"phoneExt":33,"email":133},"Qingxian Huang","+86(0351)4651772","yhdhuang@163.com",{"type":135,"investigatorFullName":66,"investigatorTitle":5,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","100611335","phase-2-study-to-evaluate-the-efficacy-and-safety-of-neo-adjuvant-tace-and-atezolizumab-plus-bevacizumab-therapy-for-high-risk-recurrent-hepatocellular-carcinamo-100611335",false,"NCT07239245","Study to Evaluate the Efficacy and Safety of Neo-Adjuvant TACE and Atezolizumab Plus Bevacizumab Therapy for High-Risk Recurrent Hepatocellular Carcinamo","Efficacy and Safety of Transarterial Chemoembolization (TACE) Combined With Atezolizumab Plus Bevacizumab in Neoadjuvant Therapy for Patients With Hepatocellular Carcinoma: an Open-label, Single-arm, Multicenter, Prospective, Phase II Clinical Study","ATTACH","Inclusion Criteria:\n\n1. Signed Informed Consent Form available\n2. Patients ≥ 18 years and ≤75years of age at time of signing Informed Consent Form\n3. Diagnosis of HCC confirmed by histology\n4. Initially resectable with high-risk recurrence factors. High-risk features for resected patients include tumor size \\>5 cm, tumor number \\>3, vascular invasion (microvascular invasion or macrovascular invasion - Vp1\u002FVp2 - of the portal vein) and poor tumor differentiation (defined as Grade 3 or 4).\n\n   Up to three tumors, with largest tumor \\>5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1\u002FVp2) or poor tumor differentiation (Grade 3 or 4) Four or more tumors, with largest tumor ≤5 cm regardless of vascular invasion (microvascular invasion or macrovascular invasion of Vp1\u002FVp2) or poor tumor differentiation (Grade 3 or 4) Up to three tumors, with largest tumor ≤5 cm with vascular invasion (microvascular invasion or macrovascular invasion of Vp1\u002FVp2) and\u002For poor tumor differentiation (Grade 3 or 4)\n5. Measurable disease (at least one target lesion) according to RECIST v1.1 as determined by the investigator\n6. Child-Pugh A\n7. ECOG PS 0～1\n8. No prior locoregional or systemic treatment for HCC\n9. Negative HIV test at screening\n\nExclusion Criteria:\n\n1. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma, recurrent HCC and diffuse HCC\n2. Clinically diagnosed hepatic encephalopathy in the last 6 months\n3. Autoimmune hepatitis (requiring liver puncture)\n4. History of organ transplantation\n5. Clinical symptoms of pleural effusion, ascites, pericardial effusion, and any history of kidney disease or nephrotic syndrome\n6. Treatment with investigational therapy within 28 days prior to initiation of study treatment\n7. Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or that are at high risk for bleeding\n8. A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment\n9. Known severe allergic reaction to contrast (e.g., anaphylaxis).\n10. Pregnancy or lactating women.\n11. Inability to provide informed consent.","ALL","18 Years","75 Years",{"count":148,"type":149},30,"ESTIMATED","INTERVENTIONAL",[152],"PHASE2","This is an open-label, single-arm, multicenter, prospective, phase II clinical study to evaluate the efficacy and safety of TACE combined with Atezolizumab and Bevacizumab as neoadjuvant treatment in Hepatocellular Carcinoma.",[155],"Resectable Hepatocellular Carcinoma With High Risk of Recurrence",[157,158,159,52],"Hepatocellular Carcinoma","Neoadjuvant therapy","TACE","2025-11-24",{"date":162,"type":163},"2025-11-25","ACTUAL",{"date":165,"type":163},"2025-11-12",{"date":167,"type":149},"2030-11-10",{"name":5,"class":6},4]