[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514900":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":42,"centralContacts":47,"locations":57,"responsibleParty":74,"collaborators":77,"id":88,"slug":89,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":51,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":51,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":109,"overallStatus":60,"whyStopped":51,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"TACE plus Atezolizumab\u002FBevacizumab and I-125 Seeds Brachytherapy (TACE-AB-I)","EXPERIMENTAL","TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.\n\nAtezolizumab\u002Fbevacizumab (1,200 mg atezolizumab plus 15 mg\u002Fkg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.\n\nTACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.",[13,14,15],"Procedure: I-125 Seeds Brachytherapy in PVTT","Procedure: Transcatheter arterial chemoembolization","Drug: Atezolizumab plus Bevacizumab",{"label":17,"type":18,"description":19,"interventionNames":20},"TACE and Atezolizumab\u002FBevacizumab (TACE-AB)","ACTIVE_COMPARATOR","TACE will be performed for the patients after randomization. Atezolizumab\u002Fbevacizumab (1,200 mg atezolizumab plus 15 mg\u002Fkg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.\n\nTACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.",[14,15],[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","I-125 Seeds Brachytherapy in PVTT","Iodine125 seed implantation into the PVTT was conducted 3-7 days after TACE when the results of the liver function tests were comparable to those obtained before TACE. Pre-procedural planning was conducted using a three-dimensional conformal radiation therapy treatment planning system (TPS) to determine the number of Iodine125 seeds required, the target location for implantation, the best percutaneous puncture site and the access route. The targeted zone for implantation was the tumour thrombosis in the segmental portal vein, left\u002Fright portal vein. Implantation was guided by CT, and the Iodine125 seeds were implanted into the PVTT using 18 G needles and the implantation gun that housed the Iodine125 seeds in the cartridge chamber.",[9],[28],"Iodine-125 Seeds Implantation",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Transcatheter arterial chemoembolization","TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).",[17,9],[34],"TACE",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DRUG","Atezolizumab plus Bevacizumab","Atezolizumab\u002Fbevacizumab (1,200 mg atezolizumab plus 15 mg\u002Fkg bevacizumab intravenously every 3 weeks) .",[17,9],[41],"atezolizumab-bevacizumab; Atez\u002FBev treatment",[43],{"name":44,"affiliation":45,"role":46},"Mingsheng Huang, M.D. & Ph.D.","Department of Interventional Radiology, The Third Affiliated Hospital of Sun Yat-sen University","PRINCIPAL_INVESTIGATOR",[48,53],{"name":44,"role":49,"phone":50,"phoneExt":51,"email":52},"CONTACT","+86-02085253416",null,"huangmsh@mail.sysu.edu.cn",{"name":54,"role":49,"phone":55,"phoneExt":51,"email":56},"Luwen Mu, M.D.","+86-13660534361","mulw@mail.sysu.edu.cn",[58],{"facility":59,"status":60,"city":61,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"The Third Affiliated Hospital of Sun Yat-Sen University","RECRUITING","Guangzhou","510630","China","CN",{"type":66,"coordinates":67},"Point",[68,69],113.25,23.11667,{"lat":69,"lon":68},[72],{"name":73,"role":49,"phone":51,"phoneExt":51,"email":51},"Mingsheng Huang",{"type":46,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":51,"oldOrganization":51},"Huang Mingsheng","The director of Department of Interventional Radiology",[78,80,82,84,86],{"name":79,"class":6},"Sun Yat-Sen University Cancer Center",{"name":81,"class":6},"Fifth Affiliated Hospital, Sun Yat-Sen University",{"name":83,"class":6},"Second Affiliated Hospital of Guangzhou Medical University",{"name":85,"class":6},"Maoming People's Hospital",{"name":87,"class":6},"Shandong Province Third hospital","100514900","tace-plus-atezolizumabbevacizumab-and-i-125-seeds-brachytherapy-for-hcc-with-branch-pvtt-100514900",false,"NCT05984511","TACE Plus Atezolizumab\u002FBevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT","TACE Plus Atezolizumab\u002FBevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial","Inclusion Criteria:\n\n* Age between18 and 75 years;\n* Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n* Type I PVTT or type II PVTT;\n* Child-Pugh class A;\n* Eastern Cooperative Group performance status (ECOG) score of 0-1;\n* No prior systemic therapy for HCC.\n* Adequate hematologic and end-organ function;\n* At least one measurable intrahepatic target lesion.\n\nExclusion Criteria:\n\n* Diffuse HCC;\n* Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular\u002Fcholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;\n* Evidence of extrahepatic spread (EHS);\n* Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;\n* Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \\>CTCAE grade 3 within 4 weeks prior to randomization;\n* Active or history of autoimmune disease or immune deficiency;\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high risk for bleeding;\n* A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment;\n* Evidence of bleeding diathesis or significant coagulopathy;\n* Pregnant or breastfeeding females;\n* Significant cardiovascular disease;\n* Severe infection, such as active tuberculosis;\n* Serious medical comorbidities;\n* History of organ or cells transplantation;\n* History of other uncurable malignancies.","ALL","18 Years","75 Years",{"count":99,"type":100},234,"ESTIMATED","INTERVENTIONAL",[103],"NA","The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab\u002FBevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab\u002FBevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I\u002FII PVTT (Based on Cheng's PVTT classification).",[106,107,108],"Hepatocellular Carcinoma","Hepatic Portal Vein Tumor Invasion","Tumor Thrombus",[110,111,112,113,37],"Hepatocellular Carcinoma (HCC)","Portal vein tumor thrombosis (PVTT)","Transcatheter arterial chemoembolization (TACE)","I-125 Seeds Brachytherapy","2025-02-07",{"date":116,"type":117},"2025-02-11","ACTUAL",{"date":119,"type":117},"2023-08-30",{"date":121,"type":100},"2029-08-01",{"name":5,"class":6},1]