[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546614":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":55,"collaborators":57,"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":32,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DEB-TACE+HAIC","EXPERIMENTAL","For DEB-TACE, superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, 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 RALOX-based regimen is intra-arterially administered.\n\nDuring follow-up, the treatment will be repeated on demand (about 4-week interval) based on the evaluation of the follow-up laboratory and imaging examination.",[13],"Drug: DEB-TACE+HAIC",{"label":15,"type":16,"description":17,"interventionNames":18},"DEB-TACE","ACTIVE_COMPARATOR","Superselective catheterization is performed and CalliSpheres loaded with pirarubicin is use for chemoembolization. The embolization end point was blood stasis of the tumor-feeding arteries. In patients with huge or bilobar multiple lesions, 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.",[19],"Drug: DEB-TACE",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.\n\nRALOX-based regimen for hepatic arterial infusion chemotherapy: oxaliplatin, 85 mg\u002Fm2 infusion for 2 hours; Raltitrexed, 3 mg\u002Fm2 infusion for 0.5 hour.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"CalliSpheres (100-300 µm) loaded with pirarubicin for transarterial chemombolization: Typically, one vial of the beads was loaded with 60 mg pirarubicin. If blushed tumors is still visible after the embolization with one vial of beads, regular microspheres (8spheres) with diameters of 100-700 μm are additionally injected.",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510260","China","CN",{"type":39,"coordinates":40},"Point",[41,42],113.25,23.11667,{"lat":42,"lon":41},[45,50,52],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Kangshun Zhu, Dr.","CONTACT","+86-20-34156205","zhksh010@126.com",{"name":46,"role":51,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Mingyue Cai, Dr.","SUB_INVESTIGATOR",{"type":56,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[58,60,63],{"name":59,"class":6},"Zhongshan People's Hospital, Guangdong, China",{"name":61,"class":62},"Guangzhou Development District Hospital","UNKNOWN",{"name":64,"class":62},"The Affiliated Shunde Hospital of Jinan University","100546614","phase-2-deb-taceralox-haic-vs-deb-tace-for-large-hcc-100546614",false,"NCT06397235","DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC","DEB-TACE in Combination With or Without RALOX-based HAIC for Unresectable Large Hepatocellular Carcinoma: A Randomized, Controlled Trial","Inclusion Criteria:\n\n* HCC confirmed by histology\u002Fcytology or diagnosed clinically.\n* At least one measurable intrahepatic target lesion.\n* The largest tumor size \\> 7 cm.\n* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.\n* Child-Pugh score 5-7.\n* ECOG performance status ≤ 1.\n* Adequate organ and hematologic function with platelet count ≥75×10\\^9\u002FL, leukocyte \\>3.0×10\\^9\u002FL, Neutrophil count ≥1.5×10\\^9\u002FL, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.\n\nExclusion Criteria:\n\n* Macrovascular invasion or extrahepatic metastasis.\n* Diffuse HCC.\n* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.\n* Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, 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* Gastrointestinal bleeding within 30 days, or other bleeding\\> CTCAE grade 3.\n* History of organ or cells transplantation.\n* Pregnant or lactating patients.","ALL","18 Years","75 Years",{"count":76,"type":77},130,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).",[83],"Hepatocellular Carcinoma Non-resectable",[85,86,87,88,89,90],"Hepatocellular Carcinoma","transarterial chemoembolization","drug-eluting beads","hepatic artery infusion chemotherapy","oxaliplatin","raltitrexe","2025-02-18",{"date":93,"type":94},"2025-02-20","ACTUAL",{"date":96,"type":94},"2024-05-01",{"date":98,"type":77},"2028-04-30",{"name":5,"class":6},1]