[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563889":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":67,"collaborators":71,"id":73,"slug":27,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":27,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":93,"overallStatus":50,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Sun Yat-sen University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Transjugular intrahepatic portosystemic shunt","EXPERIMENTAL","A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the participants received a diuretic treatment and a salt-limited diet.",[13,14,15],"Procedure: Transjugular intrahepatic portosystemic shunt","Drug: Lenvatinib","Drug: PD-1 inhibitor",[17,22,28],{"type":18,"name":9,"description":11,"armGroupLabels":19,"otherNames":20},"PROCEDURE",[9],[21],"TIPS",{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Lenvatinib","12 mg (body weight ≥60 kg) , 8 mg (body weight \\\u003C60 kg",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"PD-1 inhibitor","Tislelizumab (200mg intravenously every 3 weeks), Sintilimab (200mg intravenously every 3 weeks), Camrelizumab (200mg intravenously every 3 weeks)",[9],[33],{"name":34,"affiliation":35,"role":36},"Feng Duan","Chinese PLA General Hospital","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":27,"email":42},"Qunfang Zhou, MD","CONTACT","86 19868000115","zhouqun988509@163.com",{"name":44,"role":40,"phone":45,"phoneExt":27,"email":46},"Feng Duan, MD","86 13910984586","duanfeng@vip.sina.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Chinese PLA General hospital","RECRUITING","Beijing","None Selected","100853","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63,65],{"name":39,"role":40,"phone":64,"phoneExt":27,"email":42},"8619868000115",{"name":44,"role":40,"phone":66,"phoneExt":27,"email":46},"8613910984586",{"type":68,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Zhou Qunfang","Clinical Professor",[72],{"name":35,"class":6},"100563889",false,"NCT06622031","TIPS Combined With Lenvatinib and PD-1 Inhibitor for Advanced HCC With Main Trunk PVTT","Transjugular Intrahepatic Portosystemic Shunt Combined With Lenvatinib and PD-1 Inhibitor for Advanced Hepatocellular Carcinoma With Main Trunk Portal Vein Tumor Thrombus: a Multicenter Phase II Study","Inclusion Criteria:\n\n1. diagnosis of primary HCC, confirmed histologically or clinically according to the criteria of the American Association for the Study of Liver Diseases;\n2. presence of PVTT with III-IV grade by Cheng's criteria;\n3. having PVTT induced portal hypertension;\n4. with or without PVTT induced acute variceal bleeding;\n5. metastases with limited five sites and no more two organs involved;\n6. Number of Intrahepatic tumors were no more than five;\n7. receipt of Lenvatinib and PD-1 inhibitor as the first-line systemic therapy;\n8. classified as Child-Pugh class A or B and having an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2;\n9. no history of other malignancies;\n10. agreed to participated in this clinical trial;\n11. Hemameba ≥3.0 x109\u002FL, neutrophil ≥1.5x109\u002FL, hemoglobin≥10.0 g\u002FL, platelet≥100x 109\u002FL, ALT; AST; bilirubin ≤1.5-fold normal, GFR≥60ml\u002Fmin.\n\nExclusion Criteria:\n\n1. recurrent HCC;\n2. PVTT at I-II grade by Cheng's criteria;\n3. age \\\u003C 18 years or \\> 75 years;\n4. advanced HCC with more than five metastases;\n5. Number of Intrahepatic tumors were more than five;\n6. no response to Lenvatinib;\n7. life expectancy less than 3 months.","ALL","18 Years","75 Years",{"count":83,"type":84},42,"ESTIMATED","INTERVENTIONAL",[87],"NA","Hepatocellular carcinoma (HCC) with main trunk portal vein tumor thrombus (PVTT) has poor prognosis. The main lethiferous factor is the upper gastrointestinal hemorrhage by PVTT-related portal hypertension, then the second is the tumor-caused death. It is vital to prevent the portal hypertension by PVTT.",[90,91,92],"Hepatocellular Carcinoma","Portal Vein Tumor Thrombus","Systemic Therapy",[94,24,95,96,97,9,98],"Advanced hepatocellular carcinoma","Sintilimab","Camrelizumab","Tislelizumab","Main trunk portal vein tumor thrombus","2025-01-09",{"date":101,"type":102},"2025-01-13","ACTUAL",{"date":104,"type":102},"2024-10-01",{"date":106,"type":84},"2027-08-30",{"name":5,"class":6},1]