[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586002":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":47,"responsibleParty":64,"collaborators":32,"id":67,"slug":32,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":32,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":32,"enrollmentInfo":75,"targetDuration":32,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":50,"whyStopped":32,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Zhongda Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"SIRT Group","EXPERIMENTAL","Each Participant will underwent a single intra-arterial infusion of yttrium-90 carbon microspheres (NRT6003 injection)\\].",[13],"Procedure: SIRT",{"label":15,"type":16,"description":17,"interventionNames":18},"cTACE Group","ACTIVE_COMPARATOR","Each Participant will underwent conventional transarterial chemoembolization (cTACE).",[19],"Procedure: cTACE",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","SIRT","Y-90 administered",[9],[27],"Yttrium-90 [90Y]",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"cTACE","cTACE administered",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Gao-Jun Teng","Zhongda Hospital, Soueast University","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Hai-Dong Zhu","CONTACT","+86-25-83272121","zhuhaidong9509@163.com",{"name":45,"role":41,"phone":42,"phoneExt":32,"email":46},"Lei Zhang","llei589@126.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Zhongda Hospital, Southeast University","RECRUITING","Nanjing","Jiangsu","210009","China","CN",{"type":57,"coordinates":58},"Point",[59,60],118.77778,32.06167,{"lat":60,"lon":59},[63],{"name":40,"role":41,"phone":32,"phoneExt":32,"email":43},{"type":37,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Gao-jun Teng","Director of Interventional and Vascular Surgery Department","100586002",false,"NCT06909708","SIRT Versus cTACE for Unresectable HCC (CHANCE2506)","SIRT (Yttrium-90 Carbon Microspheres) Versus cTACE for Unresectable Hepatocellular Carcinoma: A Multicenter, Prospective, Open-label, Phase 3 Trial (CHANCE2506)","Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group performance status ≤ 1;\n2. Expected survival time ≥ 3 months;\n3. Confirmed hepatocellular carcinoma based on CNLC guidelines;\n4. Without extrahepatic metastases, unresectable or refuse surgical resection;\n5. At least one well defined tumor (mRECIST 1.1);\n6. Tumor burden≤50% of the total liver volume;\n7. Child-Pugh score≤7;\n8. Adequate organ function: # Blood routine: absolute neutrophil count ≥ 1.5×10\\^9\u002FL; platelet≥75×10\\^9\u002FL; hemoglobin≥90 g\u002FL; # Liver function: total bilirubin≤2 times upper limit of normal (ULN); alanine transaminase and aspartate aminotransferase≤5.0 ULN; alkaline phosphatase≤2.5 ULN; Albumin\\>30 g\u002FL; # Renal function: Cr≤1.5 ULN; creatinine clearance≥50 mL\u002Fmin; # Coagulation function: international normalized ratio, prothrombin time and activated partial thromboplastin time were less than 1.5 ULN;\n9. Women and men of childbearing age must agree to take strict and effective contraceptive measures during the study period and within 6 m after the end of the trial.\n\nExclusion Criteria:\n\n1. With previous history of hepatic encephalopathy;\n2. Extrahepatic disease or combined with other malignant tumors;\n3. Infiltrative hepatocellular carcinoma ;\n4. With prior antitumor therapies, including liver transplantation, hepatectomy, ablation, TACE, chemotherapy, radiotherapy, targeted therapy or immunotherapy;\n5. With hepatic artery malformation and unable to undergo TACE or SIRT;\n6. Allergy to contrast agents or anesthetics\n7. With clinical manifestations of portal hypertension, moderate-severe or refractory ascites, or decompensated liver cirrhosis, or moderate-to-severe esophageal\u002Fgastric varices;\n8. With severe pulmonary insufficiency (forced expiratory volume at one second \u002F forced vital capacity\\\u003C50% or forced expiratory volume at one second \u002Fpredicting value\\\u003C50% or maximum volume per minute\\\u003C50 L\u002Fmin);\n9. The single lung radiation absorbed dose\\>30 Gy;\n10. Tumor thrombus in main portal vein or hepatic artery or hepatic vein or bile duct;\n11. Serious infections in active stage or need systematic treatment;\n12. Pregnant and lactating women;\n13. With positive results of HIV antibody test;\n14. HBV DNA or HCV RNA positive;\n15. With active syphilis or tuberculosis;\n16. 99mTc-MAA imaging (patients exclusion meet all criteria):\n\n1\\) Perfusion area covers all intrahepatic tumors (including non-target lesions) and non-perfused liver volume ≥30% of total liver volume; 2) Tumor dose ≥400 Gy for 1-2 hepatic segments; Perfused normal liver dose (PNLD): 120 Gy \\\u003C PNLD \\\u003C1000 Gy; Tumor dose ≥200 Gy (recommended ≥400 Gy) and PNLD \\\u003C120 Gy with other condition; 3) No gastrointestinal shunt , or shunt amendment by endovascular techniques (reassessment required); 4) cTACE should cover all intrahepatic lesions.","ALL","18 Years",{"count":76,"type":77},108,"ESTIMATED","INTERVENTIONAL",[80],"NA","To evaluate the efficacy and safety of yttrium-90 carbon microspheres versus cTACE in patients with unresectable hepatocellular carcinoma",[83],"Unresectable Hepatocellular Carcinoma",[85,86,87,88],"HCC","TACE","Selective internal radiation therapy","Yttrium-90","2025-04-06",{"date":91,"type":92},"2025-04-09","ACTUAL",{"date":94,"type":92},"2025-04-03",{"date":96,"type":77},"2027-01-30",{"name":5,"class":6},1]