[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619121":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":44,"locations":10,"responsibleParty":49,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":10,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":10,"overallStatus":69,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":10},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"TACE-based combination treatment cohort",null,"Patients in this group were treated with TACE plus a PD-1 inhibitor and lenvatinib",[13,14,15],"Procedure: TACE","Drug: PD-1inhibitors","Drug: Lenvatinib",{"label":17,"type":10,"description":18,"interventionNames":19},"HAIC-based combination treatment cohort","Patients in this group were treated with HAIC plus a PD-1 inhibitor and lenvatinib",[20,14,15],"Procedure: HAIC",[22,27,31,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":10},"PROCEDURE","TACE","TACE blocks the tumor's blood supply while delivering high concentrations of chemotherapy agents directly into the hepatic artery. Patients received on-demand TACE until the end of the study or tumor progression.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":10},"HAIC","HAIC involves the continuous infusion of high-dose chemotherapy into the hepatic artery via an indwelling catheter, enabling prolonged and deep tumor exposure. Patients received on-demand HAIC until the end of the study or tumor progression.",[17],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":10},"DRUG","PD-1inhibitors","200mg was given intravenously every three weeks.",[17,9],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":10},"Lenvatinib","The dose is determined by body weight, body weight greater than or equal to 60kg, 12mg, oral; Less than 60kg, 8mg, orally.",[17,9],[41],{"name":42,"affiliation":5,"role":43},"Wanguang Zhang","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":10,"email":48},"CONTACT","13886195965","wgzhang@tjh.tjmu.edu.cn",{"type":43,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Wan-Guang Zhang","Professor","100619121","tace-versus-haic-combined-with-pd-1-inhibitors-and-lenvatinib-for-unresectable-hepatocellular-carcinoma-100619121",false,"NCT07340502","TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma","TACE Versus HAIC, Combined With PD-1 Inhibitors and Lenvatinib for Unresectable Hepatocellular Carcinoma: a Multicenter, Prospective, Observational Cohort Study","Inclusion Criteria:\n\n* Aged between 18 and 75 years;\n* Tumor stage classified as BCLC-A to -C, with no evidence of extrahepatic metastasis;\n* Newly diagnosed, treatment-naïve hepatocellular carcinoma with no prior anticancer therapy;\n* Child-Pugh liver function score ≤ 7;\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1;\n* Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain).\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis;\n* Concurrent other malignancies or recurrent hepatocellular carcinoma;\n* Any active, known, or suspected autoimmune disease;\n* History of hypersensitivity to any component of PD-1 inhibitors or lenvatinib;\n* Human immunodeficiency virus (HIV) infection; or active viral hepatitis (e.g., hepatitis B or C);\n* Tumor thrombus involving the inferior vena cava, hepatic veins, or the main portal vein trunk.","ALL","18 Years","75 Years",{"count":63,"type":64},364,"ESTIMATED","OBSERVATIONAL","Although the combination of transarterial chemoembolization (TACE) with PD-1 inhibitor plus lenvatinib has become a new standard, the therapeutic efficacy for unresectable hepatocellular carcinoma (uHCC) still requires improvement, as TACE remains limited for patients with multifocal lesions, hypovascular tumors, or those complicated with portal vein tumor thrombosis (PVTT). Hepatic arterial infusion chemotherapy (HAIC), as an alternative locoregional therapy, has demonstrated advantages in treating these refractory cases. Therefore, this study innovatively designs a prospective cohort study to conduct a comparison of the two triple-combination regimens-\"HAIC plus PD-1 inhibitor and lenvatinib\" versus \"TACE plus PD-1 inhibitor and lenvatinib\"-in terms of real-world efficacy and safety, with a focus on enrolling patients who are likely to have suboptimal responses to TACE. This research aims to provide high-level evidence for selecting the optimal combined locoregional strategy for uHCC patients, thereby directly guiding clinical practice and potentially advancing the optimization of treatment strategies and personalized precision medicine to improve patient survival outcomes.",[68],"HCC","NOT_YET_RECRUITING","2026-01-06",{"date":72,"type":73},"2026-01-14","ACTUAL",{"date":75,"type":64},"2026-01-31",{"date":77,"type":64},"2028-12-31",{"name":5,"class":6}]