[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561730":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":24,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":24,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TACE with Thermosensitive Nanogel Embolic Agent","EXPERIMENTAL","Equipment:\n\nThermosensitive Nanogel Embolic Agent",[13],"Device: Thermosensitive Nanogel Embolic Agent",{"label":15,"type":16,"description":17,"interventionNames":18},"TACE with Embosphere Microspheres","ACTIVE_COMPARATOR","Equipment:\n\nEmbosphere Microspheres",[13],[20],{"type":21,"name":22,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Thermosensitive Nanogel Embolic Agent",[15,9],null,[26],{"name":27,"affiliation":5,"role":28},"Gao-Jun Teng, M.D.","PRINCIPAL_INVESTIGATOR",[30],{"name":31,"role":32,"phone":33,"phoneExt":24,"email":34},"Lei Zhang, M.D.","CONTACT","+86 13770106862","llei589@126.com",[36],{"facility":37,"status":38,"city":39,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Gao-Jun Teng","RECRUITING","Nanjing","China","CN",{"type":43,"coordinates":44},"Point",[45,46],118.77778,32.06167,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":24,"phoneExt":24,"email":24},"Gao-Jun Teng, MD",{"type":28,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Gao-jun Teng","Dean","100561730","tace-with-thermosensitive-nanogel-versus-embosphere-for-hcc-100561730",false,"NCT06593964","TACE With Thermosensitive Nanogel Versus Embosphere for HCC","Safety and Efficacy of TACE With Thermosensitive Nanogel Embolic Agent Versus Embosphere for Hepatocellular Carcinoma: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial","Inclusion Criteria:\n\n1. Chinese Liver Cancer Staging Scheme, stage IIb-Illa, as well as those with stage Ia-Ila HCC, unsuitable or unwilling to undergo surgical resection, transplantation, or ablation;\n2. Liver function status: Child-Pugh A or B\n3. Eastern Cooperative Oncology Group score: 0-2 points;\n4. With at least one measurable, unembolized liver tumor lesion (1-10 cm) ;\n5. Willing to participate in this trial and sign the informed consent.\n\nExclusion Criteria:\n\n1. The target lesion has been embolized before or require combined with other treatment(s);\n2. Diffuse or with extrahepatic metastasis;\n3. Coagulation dysfunction (PT prolonged beyond the upper limit of normal for 3 seconds);\n4. Severe renal dysfunctions (creatinine clearance rate \\\u003C30 ml\u002Fmin);\n5. Severe liver dysfunctions (alanine aminotransferase or aspartate aminotransferase exceeding the upper limit of normal by 5 times);\n6. Main portal vein was completely occluded and no collateral blood supply was established;\n7. With uncorrectable arteriovenous fistula or portal vein fistula;\n8. Severe cachexia or hepatic encephalopathy;\n9. With active infection;\n10. Significant reductions in white blood cells or platelets (white blood cells\\\u003C3.0x109\u002FL, platelets\\\u003C50x109\u002FL) that cannot be corrected;\n11. Pregnant or lactating women;\n12. Difficulty in selective catheterization;\n13. With the severe risk of non-target embolization;\n14. Severely allergic to contrast agents or the embolic materials;\n15. Participating in ongoing trial;\n16. Unsuitable judged by the investigator.","ALL","18 Years","80 Years",{"count":65,"type":66},188,"ESTIMATED","INTERVENTIONAL",[69],"NA","To verify the safety and efficacy of TACE withThermosensitive Nanogel Embolic Agent for HCC.",[72],"Unresectable Hepatocellular Carcinoma",[74,75],"Hepatocellular carcinoma","Transarterial Chemoembolization","2024-09-09",{"date":78,"type":79},"2024-09-19","ACTUAL",{"date":81,"type":66},"2024-09-10",{"date":83,"type":66},"2026-04-30",{"name":5,"class":6},1]