[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546613":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":29,"responsibleParty":46,"collaborators":19,"id":48,"slug":19,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":19,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Sin-Bev-SIRT","EXPERIMENTAL","Sintilimab, Bevacizumab plus SIRT",[13],"Drug: Sin-Bev-SIRT",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Sintilimab 200mg I.V. q3w and bevacizumab 7.5mg\u002Fkg I.V. q3w will be started at 3-7 days after the first SIRT. Treatment of sintilimab and bevacizumab will last up to 24 months. Patients will be allowed to have sintilimab or bevacizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Mingyue Cai, Dr.","CONTACT","+86-20-34156205","cai020@yeah.net",{"name":27,"role":23,"phone":24,"phoneExt":19,"email":28},"Kangshun Zhu, Dr.","zhksh010@163.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"the Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510260","China",{"type":38,"coordinates":39},"Point",[40,41],113.25,23.11667,{"lat":41,"lon":40},[44,45],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":27,"role":23,"phone":24,"phoneExt":19,"email":28},{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100546613",false,"NCT06397222","Sintilimab Plus Bevacizumab and SIRT for Intermediate-advanced HCC","Sintilimab, Bevacizumab Plus Y-90 Selective Internal Radiation Therapy for Patients With Unresectable Intermediate-advanced Hepatocellular Carcinoma: a Prospective, Single-center, Single Arm Trial","Inclusion Criteria:\n\n* Unresectable HCC (BCLC stage B\u002FC or CNLC II\u002FIII) with diagnosis confirmed by histology\u002Fcytology or clinically\n* At least one measurable untreated lesion\n* Intrahepatic tumors can be treated with 1-2 sessions of SIRT\n* Child-Pugh score 5-7\n* Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1\n* Life expectancy of at least 3 months\n* Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\\\u003C10\\^3 IU\u002FmL\n* Patients with hepatitis C need to finish the anti-HCV treatment\n\nExclusion Criteria:\n\n* tumor extent ≥70% liver occupation\n* Tumor thrombus involving main portal vein or both the first left and right branches of portal vein\n* Vena cava invasion\n* Central nervous system metastasis\n* Metastatic disease that involves major airways or blood vessels\n* Patients who previously received hepatic arterial infusion chemotherapy (HAIC), transarterial chemoembolization (TACE), transarterial embolization (TAE), radiotherapy, systemic therapy for HCC\n* History of organ and cell transplantation\n* Prior esophageal and\u002For gastric varices bleeding\n* Hepatic dysfunction, such as ascites, esophagogastric varices, hepatic encephalopathy\n* Evidence of portal hypertension with high risk of bleeding\n* Use of immunosuppressive medications within 4 weeks prior to the first dose of study treatment\n* Major surgical procedure or unhealed wound, ulcer, or fracture within 4 weeks prior to the first dose of study treatment\n* Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion, surgical or localized treatment, or ongoing drug therapy\n* Peripheral blood white blood cell count \\\u003C3×10\\^9\u002FL and platelet count \\\u003C50×10\\^9\u002FL\n* Prolonged prothrombin time \\>4 seconds\n* Severe organ (heart, lung, kidney) dysfunction\n* History of other malignancies\n* Co-infection with hepatitis B and C viruses\n* Human immunodeficiency virus infection\n* Pregnant or lactating patients","ALL","18 Years","75 Years",{"count":58,"type":59},23,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus Y-90 selective internal radiation therapy (SIRT) for patients with unresectable intermediate-advanced hepatocellular carcinoma (HCC).",[65],"Hepatocellular Carcinoma Non-resectable",[67,68,69,70],"Hepatocellular Carcinoma","Sintilimab","Bevacizumab","Yttrium-90","2024-05-05",{"date":73,"type":74},"2024-05-07","ACTUAL",{"date":76,"type":74},"2024-05-01",{"date":78,"type":59},"2027-04-30",{"name":5,"class":6},1]