[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616840":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":28,"locations":10,"responsibleParty":37,"collaborators":10,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":44,"acronym":10,"eligibilityCriteria":45,"healthyVolunteers":42,"sex":46,"minAge":47,"maxAge":10,"enrollmentInfo":48,"targetDuration":10,"studyType":51,"phases":10,"briefSummary":52,"conditions":53,"keywords":10,"overallStatus":56,"whyStopped":10,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":10},{"fullName":5,"class":6},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Beyond UCSF Criteria Cohort",null,"HCC patients receiving conversion therapy beyond UCSF criteria",[13],"Combination Product: Locoregional Therapy (LRT) + Systemic Drug Therapy",{"label":15,"type":10,"description":16,"interventionNames":10},"Within UCSF Criteria Cohort","HCC patients within UCSF Criteria Cohort",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":10},"COMBINATION_PRODUCT","Locoregional Therapy (LRT) + Systemic Drug Therapy","Treatment regimens, doses, and durations varied based on individual clinical decisions and are collected retrospectively.",[9],[24],{"name":25,"affiliation":26,"role":27},"Caide Lu, Professor","Ningbo Medical Centre Lihuili Hospital","PRINCIPAL_INVESTIGATOR",[29,33],{"name":25,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+8613957800900","lucaide@nbu.edu.cn",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Shuqi Mao, Professor","+8617855848257","mmmaoshuqi@163.com",{"type":27,"investigatorFullName":38,"investigatorTitle":39,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"lucaide","Chief Physician\u002FProfessor","100616840","a-retrospective-study-of-safety-and-efficacy-of-locoregional-therapies-combined-with-anti-vegftkis-and-immune-checkpoint-inhibitors-for-all-comers-of-intention-to-treat-patients-with-hepatocellular-carcinoma-beyond-ucsf-criteria-before-liver-transplantation-100616840",false,"NCT07310836","A Retrospective Study of Safety and Efficacy of Locoregional Therapies Combined With Anti-VEGF\u002FTKIs and Immune Checkpoint Inhibitors for All Comers of Intention-to-treat Patients With Hepatocellular Carcinoma Beyond UCSF Criteria Before Liver Transplantation","Inclusion Criteria:\n\n* Age ≥16;\n* Clinical diagnosis of HCC;\n* CNLC Stage I-IIIA.\n\nExclusion Criteria:\n\n* Extrahepatic metastasis;\n* Type IV portal vein tumor thrombus.","ALL","16 Years",{"count":49,"type":50},300,"ESTIMATED","OBSERVATIONAL","This is a single-center, retrospective cohort study aiming to evaluate the safety and efficacy of a combined treatment strategy for patients with hepatocellular carcinoma (HCC) who are beyond the UCSF criteria but intended for liver transplantation. The primary objective is to assess the outcomes of these \"intention-to-treat\" patients who received locoregional therapies (LRT, such as TACE or radiotherapy) in combination with systemic therapy (anti-VEGF\u002FTyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors) as a \"conversion therapy\" prior to potential transplantation. This approach is distinct from traditional bridging or down-staging therapies by incorporating more aggressive systemic regimens. The study plans to enroll 300 subjects. The exposure group will include approximately 100 patients beyond UCSF criteria who received the combined conversion therapy between January 2020 and December 2024. A control group of about 200 patients who met the UCSF criteria and were directly listed for transplantation in the same period will be used for comparison. Data will be collected from medical records and the China Liver Transplant Registry (CLTR), with follow-up until December 2025.\n\nPrimary outcome measures include:\n\nObjective Response Rate (ORR) of conversion therapy per mRECIST. Rate of successful down-staging to meet UCSF criteria.\n\n1-, 2-, and 3-year overall survival (OS) rates of the intention-to-treat population.\n\nActual liver transplantation rate after successful conversion. Post-transplant 1-, 2-, and 3-year OS and recurrence-free survival (RFS) rates.\n\nSecondary outcomes involve:\n\nSafety profiles of both conversion therapy and subsequent transplantation. Analysis of factors influencing conversion success and treatment efficacy. Determination of an optimal washout period for Immune Checkpoint Inhibitors prior to transplantation.\n\nThe study seeks to provide high-level evidence for optimizing pre-transplant conversion strategies for advanced HCC patients currently outside standard transplant criteria.",[54,55],"Hepatocellular Carcinoma","Liver Transplantation","NOT_YET_RECRUITING","2025-12-16",{"date":59,"type":60},"2025-12-30","ACTUAL",{"date":62,"type":50},"2025-12-20",{"date":64,"type":50},"2026-03-31",{"name":5,"class":6}]