[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577113":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":47,"collaborators":20,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":51,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":30,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","The patient will receive induction therapy with tislelizumab and lenvatinib within 14 days after enrollment. Subsequently, within 2-7 days (the exact timing will be determined based on clinical circumstances), they will undergo Multimodal Thermal Therapy (MTT). Following the MTT procedure, on-demand TACE treatment will be administered. Starting from day 7 post-MTT (with the exact timing adjusted according to clinical conditions), the patient will resume tislelizumab and lenvatinib therapy until disease progression, occurrence of intolerable toxicity, or withdrawal of consent.",[13],"Device: Multimodal Thermal Therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Multimodal Thermal Therapy","The high-burden tumor is identified as the target lesion for treatment. A pre-treatment biopsy of the target lesion is performed to obtain tumor tissue. Multimodal ablation therapy of the target lesion is conducted under CT guidance. The treatment procedure follows the tumor ablation protocol using the multimodal therapy radiofrequency temperature-controlled mode.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"zhiping Yan, M.D","CONTACT","+86 13122806500","yan.zhiping@zs-hospital.sh.cn",[28],{"facility":29,"status":30,"city":31,"state":32,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":37,"coordinates":38},"Point",[39,40],121.45806,31.22222,{"lat":40,"lon":39},[43],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Minjie Yang","+86 02164041990","yang.mingjie@zs-hospital.sh.cn",{"type":48,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100577113","efficacy-and-safety-of-multimodal-ablation-combined-with-pd-1-monoclonal-antibody-lenvatinib-and-tace-in-the-treatment-of-unresectable-primary-hepatocellular-carcinoma-a-single-arm-single-center-clinical-study-100577113",false,"NCT06794073","Efficacy and Safety of Multimodal Ablation Combined With PD-1 Monoclonal Antibody, Lenvatinib and TACE in the Treatment of Unresectable Primary Hepatocellular Carcinoma: A Single-Arm, Single-Center Clinical Study","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender.\n2. Clinically or pathologically confirmed HCC.\n3. CNLC stage IIb-IIIa, deemed unresectable after multidisciplinary evaluation.\n4. Having radiologically evaluable, untreated target lesions for ablation, with the largest diameter of the target tumor \\>5 cm.\n5. Patients who have not undergone systemic chemotherapy, targeted therapy, or immunotherapy for hepatocellular carcinoma, or those who have been evaluated as SD (stable disease) or PD (progressive disease) after treatment..\n6. ECOG PS 0-1 and an expected survival \\>3 months.\n7. Child-Pugh score ≤7.\n\nExclusion Criteria:\n\n1. Child-Pugh class C liver dysfunction.\n2. Tumor thrombus in the main portal vein or hepatic vein.\n3. Extensive metastatic disease with an expected survival \\\u003C3 months.\n4. Severe dysfunction of major organs (liver, kidney, heart, lung, or brain).\n5. History of esophageal\u002Fgastric variceal bleeding within the past month.\n6. History of other malignancies.\n7. Last anti-tumor therapy (e.g., radiotherapy, systemic chemotherapy, or local treatment) within \\\u003C1 month.\n8. Active infection; HBV co-infection (HBV DNA ≥2000 IU\u002FmL or ≥10⁴ copies\u002FmL unless reduced by one log after antiviral therapy); HCV co-infection requiring guideline-directed antiviral treatment; HIV infection; or biliary tract inflammation.\n9. History of organ transplantation or hepatic encephalopathy.\n10. Uncorrectable coagulation disorders.\n11. Refractory massive ascites, pleural effusion, or cachexia.\n12. Pregnancy, impaired consciousness, or inability to comply with treatment.\n13. High tumor burden (sum of the largest liver lesion diameter and number of liver lesions \\>12).\n14. Any other condition deemed unsuitable by investigators that may affect study participation.","ALL","18 Years","80 Years",{"count":59,"type":60},17,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study is a prospective, single-arm, single-center trial evaluating the efficacy of TACE combined with multimodal ablation, Tislelizumab, and lenvatinib in the treatment of unresectable primary liver cancer.",[66,67,68,69,70],"Carcinoma, Hepatocellular","Neoplasms, Glandular and Epithelial","Adenocarcinoma","Digestive System Neoplasms","Liver Neoplasms",[72,73,74,75,76],"Multimodal","Tislelizumab","lenvatinib","TACE","unresectable primary liver cancer","2026-05-08",{"date":79,"type":80},"2026-05-11","ACTUAL",{"date":82,"type":80},"2026-01-31",{"date":84,"type":60},"2027-08-31",{"name":5,"class":6},1]