[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619857":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":116,"collaborators":20,"id":119,"slug":120,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":20,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":128,"enrollmentInfo":129,"targetDuration":20,"studyType":132,"phases":133,"briefSummary":135,"conditions":136,"keywords":20,"overallStatus":140,"whyStopped":20,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol arm","EXPERIMENTAL","1. TACE On-demand TACE: Use 1-2 sessions of TACE depending on the tumor condition.\n2. PD-1 inhibitor Tislelizumab 200 mg intravenous infusion, once every 3 weeks\n3. Lenvatinib Formulation: Tablets; Specifications: 4mg\u002Ftablet 8mg (for patients weighing less than 60kg) or 12mg (for patients weighing more than 60kg) once daily, taken half an hour after meals (the time of taking the medication should be as consistent as possible), discontinue medication during TACE treatment\n4. Carvedilol Formulation: Tablets; Specifications: 6.25mg\u002Ftablet Initial dose is 6.25mg, and the maintenance dose is 6.25mg - 12.5mg\u002Fday. For patients with combined arterial hypertension or heart disease, the dose of carvedilol can be further increased to treat non-liver indications.",[13],"Drug: TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol","All the enrolled patients received standard first-line treatment (TACE combined with tiragolumab and lenvatinib) and were additionally treated with carvedilol. The treatment duration of the study was one year. After the end of the treatment, the patients would be evaluated by the researchers to determine whether to continue the treatment or switch to other first-line treatments.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Wanguang Zhang","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","13886195965","wgzhang@tjh.tjmu.edu.cn",[31,47,60,72,83,97,105],{"facility":32,"status":20,"city":33,"state":34,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Clinical Oncology School of Fujian Medical University, Fujian Cancer Hospital, Department of Hepatobiliary and Pancreatic Oncology","Fuzhou","Fujian","China","CN",{"type":38,"coordinates":39},"Point",[40,41],119.30611,26.06139,{"lat":41,"lon":40},[44],{"name":45,"role":27,"phone":20,"phoneExt":20,"email":46},"Hui Zhang","zh2405@hotmail.com",{"facility":48,"status":20,"city":49,"state":50,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Department of Hepatobiliary Surgery, The First Affiliated Hospital of Guangxi Medical University","Nanning","Guangxi",{"type":38,"coordinates":52},[53,54],108.31667,22.81667,{"lat":54,"lon":53},[57],{"name":58,"role":27,"phone":20,"phoneExt":20,"email":59},"Guangdou Yuan","dr_yuangd@gxmu.edu.cn",{"facility":61,"status":20,"city":62,"state":63,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Hubei Province Tahe Hospital","Taihe","Hubei",{"type":38,"coordinates":65},[66,67],112.9882,30.86832,{"lat":67,"lon":66},[70],{"name":71,"role":27,"phone":20,"phoneExt":20,"email":20},"Huawu Zhou",{"facility":73,"status":20,"city":74,"state":63,"zip":75,"country":35,"countryCode":36,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Division of Hepato-Pancreato-Biliary Surgery, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","430000",{"type":38,"coordinates":77},[78,79],114.26667,30.58333,{"lat":79,"lon":78},[82],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},{"facility":84,"status":20,"city":85,"state":86,"zip":87,"country":35,"countryCode":36,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Organ Transplant Department,Qilu Hospital, Cheeloo College of Medicine, Shandong University,","Jinan","Shandong","250012",{"type":38,"coordinates":89},[90,91],116.99722,36.66833,{"lat":91,"lon":90},[94],{"name":95,"role":27,"phone":20,"phoneExt":20,"email":96},"Enyu Liu","liuenyu@163.com",{"facility":98,"status":20,"city":85,"state":86,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":99,"geoPoint":101,"contacts":102},"Shandong First Medical University Affiliated Provincial Hospital",{"type":38,"coordinates":100},[90,91],{"lat":91,"lon":90},[103],{"name":104,"role":27,"phone":20,"phoneExt":20,"email":20},"Hong Chang",{"facility":106,"status":20,"city":107,"state":86,"zip":20,"country":35,"countryCode":36,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Qingdao University Affiliated Hospital","Qingdao",{"type":38,"coordinates":109},[110,111],120.38042,36.06488,{"lat":111,"lon":110},[114],{"name":115,"role":27,"phone":20,"phoneExt":20,"email":20},"Jingyu Cao",{"type":24,"investigatorFullName":117,"investigatorTitle":118,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Wan-Guang Zhang","Professor","100619857","phase-2-tace-combined-with-tislelizumab-lenvatinib-and-carvedilol-for-unresectable-hcc-with-cirrhotic-portal-hypertension-100619857",false,"NCT07350070","TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for Unresectable HCC With Cirrhotic Portal Hypertension","TACE Combined With Tislelizumab, Lenvatinib, and Carvedilol for the Treatment of Unresectable Hepatocellular Carcinoma With Cirrhotic Portal Hypertension: A Multicenter, Simon Two-Stage, Single-Arm Study","Inclusion Criteria:\n\n* Aged 18-75 years.\n* At least one radiologically measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (tumor lesion long axis ≥10 mm on CT scan).\n* Newly diagnosed hepatocellular carcinoma without any prior treatment for HCC.\n* Child-Pugh liver function score ≤ 7.\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.\n* Absence of severe organic diseases affecting major organs (e.g., heart, lung, brain).\n* Compensated cirrhosis with clinically significant portal hypertension (meeting any one of the following criteria):\n\n  1. Imaging evidence (ultrasound, CT, or MRI) of portosystemic collateral circulation.\n  2. Endoscopic evidence of esophageal or gastric varices.\n  3. Liver stiffness measurement (LSM) \\>25 kPa; or LSM 20-25 kPa with platelet count \\\u003C150×10⁹\u002FL; or LSM 15-20 kPa with platelet count \\\u003C110×10⁹\u002FL.\n\nExclusion Criteria:\n\n* Decompensated cirrhosis.\n* Concurrent other malignancies or recurrent HCC.\n* Any active, known, or suspected autoimmune disease.\n* History of allergy to any component of PD-1 inhibitors, lenvatinib, or carvedilol.\n* Severe concurrent medical conditions, including asthma, significant cardiac conduction block, and sinus bradycardia.\n* Known human immunodeficiency virus (HIV) infection; or active hepatitis (e.g., hepatitis B\u002FC virus infection).\n* Presence of tumor thrombus in the inferior vena cava, hepatic vein, or main portal vein.","ALL","18 Years","75 Years",{"count":130,"type":131},78,"ESTIMATED","INTERVENTIONAL",[134],"PHASE2","In China, the majority of hepatocellular carcinoma (HCC) cases stem from chronic hepatitis B virus (HBV) infection and subsequent cirrhosis, with patients often presenting at the decompensated stage complicated by clinically significant portal hypertension (CSPH). CSPH not only limits treatment options and worsens prognosis but also leads to the frequent exclusion of such patients from pivotal clinical trials, resulting in a lack of high-level evidence for their management. Carvedilol, a non-selective beta-blocker, is a first-line therapy for portal hypertension. Emerging evidence suggests that this drug class may also modulate the tumor microenvironment and enhance the efficacy of immune checkpoint inhibitors.\n\nTo address this unmet need, this study aims to explore a novel quadruple-therapy strategy (TACE + tislelizumab + lenvatinib + carvedilol) for the treatment of unresectable HCC with concurrent cirrhotic portal hypertension. The rationale is twofold: while controlling portal hypertension and safeguarding treatment safety, carvedilol may also potentiate immunotherapy by modulating adrenergic signaling, thereby achieving dual benefits of \"liver protection\" and \"anti-cancer\" synergy. Utilizing an efficient Simon's two-stage design, this study will conduct a preliminary assessment of the regimen's efficacy and safety with minimal risk, providing essential data to inform future confirmatory research.",[137,138,139],"HCC","Liver Cirrhosis","Portal Hypertension","NOT_YET_RECRUITING","2026-01-09",{"date":143,"type":144},"2026-01-20","ACTUAL",{"date":146,"type":131},"2025-12-31",{"date":148,"type":131},"2028-06-30",{"name":5,"class":6},7]