[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655356":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":15,"studyPopulation":15,"armGroups":30,"interventions":45,"overallOfficials":67,"centralContacts":71,"locations":77,"responsibleParty":93,"collaborators":15,"id":95,"slug":96,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":15,"eligibilityCriteria":101,"healthyVolunteers":97,"sex":102,"minAge":103,"maxAge":15,"enrollmentInfo":104,"targetDuration":15,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":15,"overallStatus":113,"whyStopped":15,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Suzhou Zelgen Biopharmaceuticals Co.,Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":15},[9,13],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)","PFS evaluated by the Blinded Independent Review Committee (IRC) based on RECIST V1.1","up to 3 years",{"measure":14,"description":15,"timeFrame":16},"Overall survival (OS)",null,"up to 5 years",[18,21],{"measure":19,"description":20,"timeFrame":12},"PFS","PFS evaluated by investigator based on RECIST V1.1",{"measure":22,"description":23,"timeFrame":12},"Objective response rate (ORR)","ORR evaluated by IRC based on RECIST V1.1",{"allocation":25,"interventionModel":26,"interventionModelDescription":15,"primaryPurpose":27,"observationalModel":15,"timePerspective":15,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":15,"whoMasked":15},"NONE",[31,38],{"label":32,"type":33,"description":34,"interventionNames":35},"ZG005+Bevacizumab","EXPERIMENTAL","ZG005 20 mg\u002Fkg administered intravenously every 3 weeks (Q3W) + Bevacizumab(Avastin) 15 mg\u002Fkg administered intravenously Q3W",[36,37],"Drug: ZG005 for Injection","Drug: Bevacizumab ( Avastin)",{"label":39,"type":40,"description":41,"interventionNames":42},"Sintilimab Plus Bevacizumab","ACTIVE_COMPARATOR","Sintilimab 200 mg administered intravenously Q3W + Bevacizumab (达攸同) 15 mg\u002Fkg administered intravenouslyQ3W",[43,44],"Drug: Sintilimab","Drug: Bevacizumab",[46,53,57,61],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","ZG005 for Injection","Participants receive ZG005 20 mg\u002Fkg IV, Q3W",[32],[52],"ZG005",{"type":47,"name":54,"description":55,"armGroupLabels":56,"otherNames":15},"Bevacizumab ( Avastin)","Participants receive Bevacizumab ( Avastin) 15 mg\u002Fkg IV, Q3W",[32],{"type":47,"name":58,"description":59,"armGroupLabels":60,"otherNames":15},"Sintilimab","Participants receive Sintilimab 200mg IV, Q3W",[39],{"type":47,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Bevacizumab","Participants receive Bevacizumab 15 mg\u002Fkg IV, Q3W",[39],[66],"达攸同",[68],{"name":69,"affiliation":5,"role":70},"Jason Wu","STUDY_DIRECTOR",[72],{"name":73,"role":74,"phone":75,"phoneExt":15,"email":76},"Wei Chen","CONTACT","+86-0512-57309965","weic@zelgen.com",[78],{"facility":79,"status":15,"city":80,"state":81,"zip":15,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Nanjing Tianyinshan Hospital","Nanjing","Jiangsu","China","CN",{"type":85,"coordinates":86},"Point",[87,88],118.77778,32.06167,{"lat":88,"lon":87},[91],{"name":92,"role":74,"phone":15,"phoneExt":15,"email":15},"Shukui Qin",{"type":94,"investigatorFullName":15,"investigatorTitle":15,"investigatorAffiliation":15,"oldNameTitle":15,"oldOrganization":15},"SPONSOR","100655356","phase-3-zg005-plus-bevacizumab-vs-sintilimab-plus-bevacizumab-as-first-line-therapy-for-advanced-hepatocellular-100655356",false,"NCT07813572","ZG005 Plus Bevacizumab vs Sintilimab Plus Bevacizumab as First-Line Therapy for Advanced Hepatocellular","A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter Study of ZG005 in Combination With Bevacizumab Versus Sintilimab in Combination With Bevacizumab in the First-Line Treatment of Advanced Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Participants with histologically\u002Fcytologically confirmed unresectable or metastatic advanced HCC;\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* Barcelona Clinic Liver Cancer stage B, not suitable for local treatment and BCLC C.\n* At least one measurable lesion based on Recist1.1.\n* No prior systemic therapy for HCC.\n* Child-Pugh ≤6 , no history of hepatic encephalopathy.\n\nExclusion Criteria:\n\n* Active Central nervous system (CNS) metastasis or leptomeningeal metastases.\n* Any condition that is not suitable for participate in this study as determined by investigator.","ALL","18 Years",{"count":105,"type":106},600,"ESTIMATED","INTERVENTIONAL",[109],"PHASE3","The purpose of the study is to evaluate the efficacy of ZG005 combined with bevacizumab compared with sintilimab combined with bevacizumab in the first-line treatment of participants with advanced HCC",[112],"Hepatocellular Carcinoma","NOT_YET_RECRUITING","2026-09-04",{"date":116,"type":117},"2026-09-10","ACTUAL",{"date":119,"type":106},"2026-09",{"date":121,"type":106},"2032-09",{"name":5,"class":6},1]