[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612410":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":24,"responsibleParty":29,"collaborators":24,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":24,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":24,"enrollmentInfo":42,"targetDuration":24,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":24,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":24},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"TAF Monotherapy","TAF monotherapy (TAF 25mg qd)",[12],"Drug: TAF monotherapy",{"label":14,"type":6,"description":15,"interventionNames":16},"ETV Combined with TAF","ETV combined with TAF (ETV 0.5 mg qd +TAF 25 mg qd）",[17],"Drug: The arm will receive combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily); after HBV DNA becomes undetectable, the combination group will switch to TAF monotherapy.",[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","The arm will receive combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily); after HBV DNA becomes undetectable, the combination group will switch to TAF monotherapy.","Combination therapy (entecavir 0.5 mg once daily plus TAF 25 mg once daily)",[14],null,{"type":20,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"TAF monotherapy","TAF monotherapy (TAF 25 mg once daily)",[9],{"type":30,"investigatorFullName":31,"investigatorTitle":32,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Chan Xie","Ph.D","100612410","taf-monotherapy-versus-etv-combined-with-taf-on-the-efficacy-and-prognosis-of-immunotherapy-for-hepatitis-b-related-hepatocellular-carcinoma-100612410",false,"NCT07253220","TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma","Prospective, Randomized, Controlled Clinical Study Comparing TAF Monotherapy Versus ETV Combined With TAF on the Efficacy and Prognosis of Immunotherapy for Hepatitis B-Related Hepatocellular Carcinoma","Inclusion Criteria:\n\n* Age ≥ 18 years, positive HBsAg for ≥ 6 months, and HBV DNA ≥ 2,000 IU\u002FmL within 2 weeks before enrollment;\n\n  * Histologically or clinically confirmed unresectable or metastatic hepatocellular carcinoma, Child-Pugh class A or B, ECOG performance status 0-1, and scheduled to receive systemic immunotherapy in the Department of Infectious Diseases, The Third Affiliated Hospital of Sun Yat-sen University;\n\n    * At least one measurable lesion that has either not undergone local therapy or has progressed after local therapy, as defined by modified RECIST (mRECIST); ④ Estimated life expectancy ≥ 12 weeks; ⑤ Signed informed consent form for study participation\n\nExclusion Criteria:\n\n* Co-infection with HCV or HIV; ② History of organ transplantation; ③ Presence of cardiac or renal insufficiency, or active autoimmune disease that constitutes a contraindication to immunotherapy.","ALL","18 Years",{"count":43,"type":44},120,"ESTIMATED","INTERVENTIONAL",[47],"NA","Study Objective: To compare the efficacy and prognosis of systemic cancer therapy between TAF monotherapy and ETV plus TAF combination therapy in patients with unresectable, advanced hepatitis-B-related hepatocellular carcinoma (HBV-HCC).\n\nStudy Design: Prospective, interventional cohort study. Participants: Patients with histologically or radiologically confirmed unresectable, advanced HBV-HCC who are scheduled to receive immune-based systemic therapy at The Third Affiliated Hospital of Sun Yat-sen University. Detailed inclusion\u002Fexclusion criteria are provided below.\n\nIntervention: Enrolled participants will be assigned to receive either TAF monotherapy or ETV combined with TAF for HBV suppression.\n\nPrimary Outcome: Overall survival (OS) at 24 months after initiation of systemic therapy, compared between the two HBV-treatment strategies.\n\nSecondary Outcomes: Decline in HBV DNA and HBsAg levels at 1, 3, 12 and 24 months.\n\nSample Size: 120 HCC patients (60 per arm). Statistical Analysis: All analyses will be performed with SPSS. Continuous variables will be tested for normality (Shapiro-Wilk). Normally distributed data are presented as mean ± SD; non-normally distributed data as median (IQR). Twenty-four-month OS will be estimated by Kaplan-Meier curves and compared with a Cox proportional-hazards model adjusted for age, BCLC stage, AFP level, and ICI regimen. PFS will be compared using the log-rank test; ORR and HBV DNA undetectable rate will be compared with χ² tests. Inverse-probability-of-treatment weighting (IPTW) will address selection bias, and multiple imputation will handle missing data.",[50,51],"Hepatitis B","Hepatocellular Carcinoma (HCC)","NOT_YET_RECRUITING","2025-11-26",{"date":55,"type":56},"2025-11-28","ACTUAL",{"date":58,"type":44},"2025-12-01",{"date":60,"type":44},"2028-09-30",{"name":5,"class":6}]