[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585579":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":42,"responsibleParty":63,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Len+SIRT","EXPERIMENTAL","Lenvatinib plus SIRT",[13],"Combination Product: Lenvatinib plus SIRT",{"label":15,"type":16,"description":17,"interventionNames":18},"LEN","ACTIVE_COMPARATOR","Lenvatinib alone",[19],"Drug: Lenvatinib",[21,26],{"type":22,"name":11,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\\u003C60kg) P.O. QD will be started at 3-7 days after the first SIRT.",[9],null,{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":25},"DRUG","Lenvatinib","Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\\u003C60kg) P.O. QD.",[15],[32],{"name":33,"affiliation":5,"role":34},"Mingyue Cai, Dr.","STUDY_CHAIR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","+86-20-34156205","cai020@yeah.net",{"name":33,"role":37,"phone":38,"phoneExt":25,"email":41},"zhksh010@163.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510260","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58,59,61],{"name":33,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":60,"role":37,"phone":38,"phoneExt":25,"email":41},"Kangshun Zhu, Dr.",{"name":60,"role":62,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":64,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100585579","phase-2-lenvatinib-plus-sirt-vs-lenvatinib-in-tace-refractory-hcc-100585579",false,"NCT06904196","Lenvatinib Plus SIRT vs Lenvatinib in TACE-Refractory HCC","Lenvatinib Combined With Yttrium-90 Selective Internal Radiation Therapy (SIRT) Versus Lenvatinib Alone in TACE-Refractory Hepatocellular Carcinoma: A Prospective Non-Randomized Controlled Study","Inclusion Criteria:\n\n* Pathologically confirmed or clinically diagnosed HCC\n* Diagnosis of HCC with TACE refractoriness according to the criteria proposed by Japan Society of Hepatology (2021)\n* Patients who have Tumor recurrence after surgical resection or ablation are allowed to be included\n* At least one measurable intrahepatic target lesion\n* Child-Pugh class A\u002FB\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Tumor extent \\\u003C70% liver occupation\n* Candidates for SIRT must be confirmed suitable for SIRT after evaluation (including SPECT\u002FCT evaluation after arterial perfusion with 99Tc-MAA)\n* Adequate organ and hematologic function with platelet count ≥50×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, haemoglobin ≥85 g\u002FL, ALT and AST≤5×ULN, albumin ≥28 g\u002FL, total bilirubin ≤3× ULN, creatinine≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds\n* Life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Extrahepatic metastasis\n* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein\n* Vena cava invasion\n* Patients who received prior hepatic arterial infusion chemotherapy (HAIC), radiotherapy, or systemic therapy, for HCC\n* History of organ and cell transplantation\n* History of esophageal or gastric variceal bleeding\n* History of hepatic encephalopathy\n* History of other malignancies\n* Human immunodeficiency virus infection","ALL","18 Years","75 Years",{"count":76,"type":77},78,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This study is conducted to evaluate the efficacy and safety of lenvatinib plus SIRT (LEN+SIRT) compared with lenvatinib (LEN) alone for patients with hepatocellular carcinoma (HCC) refractory to transarterial chemoembolization (TACE).",[83],"Hepatocellular Carcinoma Non-resectable",[85,28,86],"hepatocellular carcinoma","Yttrium-90","2025-04-28",{"date":89,"type":90},"2025-04-29","ACTUAL",{"date":92,"type":90},"2025-04-01",{"date":94,"type":77},"2029-03-31",{"name":5,"class":6},1]