[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553185":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":44,"responsibleParty":63,"collaborators":38,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":38,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":38,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":46,"whyStopped":38,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"IT injection of double ICI","EXPERIMENTAL","Arm 1: intra-tumor injection of double ICIs only.",[13],"Drug: ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab",{"label":15,"type":10,"description":16,"interventionNames":17},"IT injection of double ICI and chemodrug","Arm 2: intra-tumor injection of double ICIs and a chemodrug.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"IT injection of double ICI and chemodrug plus bevacizumab","Arm 3: intra-tumor injection of double ICIs, a chemodrug, and bevacizumab.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","ipilimumab+pembrolizumab or ipilimumab+durvalumab, idarubicin, bevacizumab","This study has 3 subgroups:\n\nArm 1. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab is administrated with a total dose of 1-2mg\u002Fkg via intra-tumor fine needle injection in 10 min, every 3 weeks.\n\nArm 2. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin is administrated via intra-tumor fine needle injection in 15 min, every 3 weeks.\n\nArm 3. Ipilimumab +pembrolizumab or Ipilimumab +durvalumab combined with idarubicin plus bevacizumab is administrated via intra-tumor fine needle injection in 20 min, every 3 weeks.",[9,15,19],[29],"Local ICIs.",[31],{"name":32,"affiliation":5,"role":33},"Zhenfeng Zhang, MD, PhD","PRINCIPAL_INVESTIGATOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","+862039195966",null,"zhangzhf@gzhmu.edu.cn",{"name":41,"role":36,"phone":42,"phoneExt":38,"email":43},"Bingjia He, MD","+862039195965","464677938@qq.com",[45],{"facility":5,"status":46,"city":47,"state":38,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Guangzhou","510260","China","CN",{"type":52,"coordinates":53},"Point",[54,55],113.25,23.11667,{"lat":55,"lon":54},[58,59,61],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},{"name":60,"role":36,"phone":42,"phoneExt":38,"email":43},"Bingjia He",{"name":62,"role":33,"phone":38,"phoneExt":38,"email":38},"Zhenfeng Zhang, MD, PHD",{"type":64,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100553185","phase-2-checkpoint-inhibitor-combinations-therapy-as-first-line-for-hcc-via-it-100553185",false,"NCT06482801","Checkpoint Inhibitor Combinations Therapy as First Line for HCC Via IT","Intra-tumor Delivery of Double Checkpoint Inhibitors, Chemodrug, and\u002For Bevacizumab Therapy as First Line for Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Cytohistological confirmation is required for diagnosis of cancer.\n2. Signed informed consent before recruiting.\n3. Age above 18 years with estimated survival over 3 months.\n4. Child-Pugh class A or B\u002FChild score \\> 7; ECOG score \\\u003C 2\n5. Tolerable coagulation function or reversible coagulation disorders\n6. Laboratory examination test within 7 days prior to procedure: WBC≥3.0×10E9\u002FL; Hb≥90g\u002FL； PLT ≥50×10E9\u002FL；INR \\\u003C 2.3 or PT \\\u003C 6 seconds above control；Cr ≤ 145.5 umul\u002FL；Albumin \\> 28 g\u002FL；Total bilirubin \\\u003C 51 μmol\u002FL\n7. At least one tumor lesion meeting measurable disease criteria as determined by RECIST v1.1.\n8. Birth control.\n9. Willing and able to comply with scheduled visits, treatment plan and laboratory tests.\n\nExclusion Criteria:\n\n1. Patients participated in clinical trials of equipment or drugs (signed informed consent) within 4 weeks;\n2. Patients accompany by ascites, hepatic encephalopathy and esophageal and gastric varices bleeding;\n3. Any serious accompanying disease, which is expected to have an unknown, impact on the prognosis, include heart disease, inadequately controlled diabetes and psychiatric disorders;\n4. Patients accompanied with other tumors or past medical history of malignancy;\n5. Pregnant or lactating patients, all patients participating in this trial must adopt appropriate birth control measures during treatment;\n6. Patients have poor compliance.\n\n   Any contraindications for hepatic arterial infusion procedure:\n\n   A.Impaired clotting test (platelet count \\\u003C 60000\u002Fmm3, prothrombin activity \\\u003C 50%).\n\n   B.Renal failure \u002F insufficiency requiring hemo-or peritoneal dialysis. C.Known severe atheromatosis. D.Known uncontrolled blood hypertension (\\> 160\u002F100 mm\u002FHg).\n7. Allergic to contrast agent;\n8. Any agents which could affect the absorption or pharmacokinetics of the study drugs\n9. Other conditions that investigator decides not suitable for the trial.","ALL","18 Years","75 Years",{"count":76,"type":77},90,"ESTIMATED","INTERVENTIONAL",[80],"PHASE2","This trial is designed to investigate the safety, response rates and survival outcomes of patients with hepatocellular carcinoma by infusion of CTLA4, PD1 and PDL1 antibodies combination with chemodrug or\u002Fand bevacizumab through intra-tumor (IT).",[83,84],"Liver Cancer","Antibody",[86,87,88,89,90,91,92,93],"Hepatocellular Carcinoma","Intra-tumor injection","First line","CTLA4 antibody","PD1 antibody","PDL1 antibody","chemodrug","anti-angiogenesis","2024-06-27",{"date":96,"type":97},"2024-07-01","ACTUAL",{"date":99,"type":97},"2024-06-10",{"date":101,"type":77},"2035-12-30",{"name":5,"class":6},1]