[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601349":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":22,"centralContacts":22,"locations":22,"responsibleParty":23,"collaborators":22,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":31,"acronym":22,"eligibilityCriteria":32,"healthyVolunteers":29,"sex":33,"minAge":34,"maxAge":22,"enrollmentInfo":35,"targetDuration":22,"studyType":38,"phases":39,"briefSummary":41,"conditions":42,"keywords":22,"overallStatus":44,"whyStopped":22,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":22},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Heterogeneous Treatment Effect-Based Decision Model","ACTIVE_COMPARATOR","Participations receiving TACE alone or TACE combined with Atezolizumab plus Bevacizumab decsided by Heterogeneous Treatment Effect-Based Decision Model",[13],"Device: Heterogeneous Treatment Effect-Based Decision Model",{"label":15,"type":10,"description":16,"interventionNames":17},"TACE combined with Atezolizumab plus Bevacizumab","Participations all receiving TACE combined with Atezolizumab plus Bevacizumab",[13],[19],{"type":20,"name":9,"description":9,"armGroupLabels":21,"otherNames":22},"DEVICE",[9,15],null,{"type":24,"investigatorFullName":25,"investigatorTitle":26,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"PRINCIPAL_INVESTIGATOR","Jian Lu","Prof.","100601349","development-and-prospective-validation-of-a-heterogeneous-treatment-effect-based-decision-model-for-transarterial-chemoembolization-combined-with-or-without-atezolizumab-plus-bevacizumab-in-unresectable-hepatocellular-carcinoma-100601349",false,"NCT07109336","Development and Prospective Validation of a Heterogeneous Treatment Effect-Based Decision Model for Transarterial Chemoembolization Combined With or Without Atezolizumab Plus Bevacizumab in Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* • Aged≥18 years\n\n  * Initiated first-line Atezo+Bev.\n  * Eligible for TACE treatment or received at least one TACE within ±2 months of Atezo+Bev initiation (before Atezo+Bev start, anytime during Atezo+Bev therapy, or after Atezo+Bev discontinuation).\n  * Clinically or pathologically diagnosed uHCC before or at the initiation of Atezo\u002FBev.The evidence of being diagnosed as \"unresectable\" may include but is not limited to below:\n\n\"Unresectable\" or \"advanced\" directly documented in the medical records History of extrahepatic metastasis as evidenced clinically or by radiology, histology or cytology OR China Liver Cancer (CNLC) Stage IIIb\n\n* At least one visit record after the initiation of Atezo+Bev\n* No prior systemic therapy for HCC, especially immunotherapy\n* No prior locoregional therapy to the target lesion(s)\n* At least one measurable untreated lesion\n* ECOG Performance Status of 0-2\n\nExclusion Criteria:\n\n* • Evidence of extrahepatic spread (EHS)\n\n  * Participating in interventional clinical trials.\n  * Being a candidate for curative treatments\n  * Any condition representing a contraindication to TACE as determined by the investigators\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  * Missing critical baseline or outcome data","ALL","18 Years",{"count":36,"type":37},790,"ESTIMATED","INTERVENTIONAL",[40],"NA","Unresectable hepatocellular carcinoma (uHCC) constitutes a significant health burden in the Asia-Pacific (APAC) region, particularly in China, where it is frequently associated with hepatitis B virus (HBV) infection and diagnosed at advanced stages.\n\nTransarterial chemoembolization (TACE) remains the standard treatment for intermediate-stage hepatocellular carcinoma (HCC), though its effectiveness diminishes in unresectable HCC (uHCC) with intermediate-to-high tumor burden. The IMbrave150 trial established atezolizumab plus bevacizumab (Atezo+Bev) as a superior alternative to sorafenib, demonstrating significant survival advantages in uHCC. Given the marked heterogeneity of intermediate-stage HCC, TACE may not benefit all patients equally. The TALENTACE study investigated on-demand TACE combined with Atezo+Bev versus TACE alone in treatment-naïve uHCC patients with intermediate-to-high tumor burden across China and Japan. Results revealed a statistically significant and clinically meaningful improvement in the primary endpoint, TACE- progression-free survival (PFS), though overall survival (OS) remained immature at the time of analysis.\n\nThis situation establishes a critical and unmet need for randomized controlled trials (RCTs) combined with extensive real-world evidence (RWE) to facilitate the assessment of individualized treatment heterogeneity and provide precise treatment recommendations in China and select Asia-Pacific regions.",[43],"HCC - Hepatocellular Carcinoma","NOT_YET_RECRUITING","2025-07-30",{"date":47,"type":48},"2025-08-07","ACTUAL",{"date":50,"type":37},"2025-08-01",{"date":52,"type":37},"2027-01-01",{"name":5,"class":6}]