[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553923":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":38,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Len+DEB-TACE+HAIC","EXPERIMENTAL","Patients will receive the combination treatment of Len+DEB-TACE+HAIC.",[13],"Combination Product: Len+DEB-TACE+HAIC",{"label":15,"type":16,"description":17,"interventionNames":18},"Len+DEB-TACE","ACTIVE_COMPARATOR","Patients will receive the combination treatment of Len+DEB-TACE.",[19],"Combination Product: Len+DEB-TACE",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session.\n\nAfter each chemoembolization, the microcatheter is reserved at the main hepatic tumor-feeding artery. The FOLFOX-based regimen is intra-arterially administered.\n\nDuring follow-up, the treatment of DEB-TACE and\u002For HAIC will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.\n\nLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\\u003C60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"For DEB-TACE, superselective catheterization is performed and DEBs loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In order to reduce the risk of complications, the embolization end point was not achieved in the initial TACE but in the second or third TACE session. During follow-up, the treatment of DEB-TACE will be repeated for viable tumors based on the evaluation of the follow-up laboratory and imaging examination.\n\nLenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \\\u003C60kg) P.O. qd will be started with 7 days after the first DEB-TACE+HAIC.",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Mingyue Cai, Dr.","CONTACT","+86-20-34156205","cai020@yeah.net",{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},"Kangshun Zhu, Dr.","zhksh010@163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510260","China","CN",{"type":48,"coordinates":49},"Point",[50,51],113.25,23.11667,{"lat":51,"lon":50},[54,55,56],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":36,"role":32,"phone":33,"phoneExt":25,"email":37},{"name":36,"role":57,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100553923","phase-3-lenvatinib-plus-deb-tace-and-haic-vs-lenvatinib-plus-deb-tace-for-large-hcc-with-pvtt-100553923",false,"NCT06492395","Lenvatinib Plus DEB-TACE and HAIC vs. Lenvatinib Plus DEB-TACE for Large HCC With PVTT","A Multicentre, Randomised Controlled Study of Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization and Hepatic Arterial Infusion Chemotherapy With FOLFOX Regimen Versus Lenvatinib Plus Drug-eluting Bead Transarterial Chemoembolization for Hepatocellular Carcinoma Larger Than 7 cm With Portal Vein Tumor Thrombosis","Inclusion Criteria:\n\n* a confirmed diagnosis of HCC\n* the largest intrahepatic lesion \\>7 cm\n* presence of PVTT on imaging\n* tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment\n* Eastern Cooperative Oncology Group performance status ≤1\n* Child-Pugh class A\u002FB\n* adequate hematologic and organ function, with leukocyte count\\>3.0×10\\^9\u002FL, neutrophil count\\>1.5×10\\^9\u002FL, platelet count≥75×10\\^9\u002FL, hemoglobin 85 g\u002FL, alanine transaminase and aspartate transaminase≤5×upper limit of the normal, creatinine clearance rate≤1.5×upper limit of the normal\n* life expectancy of at least 3 months\n\nExclusion Criteria:\n\n* Diffuse HCC\n* accompanied with vena cava tumor thrombus\n* central nervous system involvement\n* previous treatment with TACE, HAIC, TAE, radiotherapy, or systemic therapy\n* organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment\n* history of other malignancies\n* uncontrollable infection\n* history of HIV\n* history of organ or cells transplantation\n* prothrombin time prolongation \\>4 s","ALL","18 Years","75 Years",{"count":71,"type":72},178,"ESTIMATED","INTERVENTIONAL",[75],"PHASE3","This study is conducted to evaluate the efficacy and safety of lenvatinib plus transarterial chemoembolization (TACE) with drug-eluting beads (DEB-TACE) and hepatic artery infusion chemotherapy (HAIC) with FOLFOX regemen (Len+DEB-TACE+HAIC) versus lenvatinib plus DEB-TACE (Len+DEB-TACE) for large hepatocellular carcinoma (\\> 7cm) with portal vein tumor thrombosis (PVTT).",[78],"Hepatocellular Carcinoma Non-resectable",[80,81,82,83,84,85],"hepatocellular carcinoma","lenvatinib","transarterial chemoembolization","drug-eluting bead","hepatic arterial infusion chemotherapy","portal vein tumor thrombosis","2025-01-26",{"date":88,"type":89},"2025-01-29","ACTUAL",{"date":91,"type":89},"2024-08-01",{"date":93,"type":72},"2027-07-31",{"name":5,"class":6},1]