[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453653":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":52,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":20,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":20,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":84,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"3 drugs","EXPERIMENTAL","Three antibodies combination against PD1, PDL1, and CTLA4.",[13],"Drug: ipilimumab +pembrolizumab +durvalumab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","ipilimumab +pembrolizumab +durvalumab","This study has 3 subgroups:\n\n1. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg\u002Fkg via vein, every 3 weeks.\n2. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 1-2mg\u002Fkg via sustained (10min) micro-pump infusion via artery, every 3 weeks.\n3. Ipilimumab +pembrolizumab +durvalumab is administrated with a total dose of 50-150mg via intra-tumor fine needle injection in 5 min, every 3 weeks.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Zhenfeng Zhang, MD, PHD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","+862039195966","zhangzhf@gzhmu.edu.cn",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Bingjia He, MD","+862039195965","464677938@qq.com",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510260","China","CN",{"type":44,"coordinates":45},"Point",[46,47],113.25,23.11667,{"lat":47,"lon":46},[50,51],{"name":23,"role":27,"phone":20,"phoneExt":20,"email":20},{"name":31,"role":27,"phone":20,"phoneExt":20,"email":20},{"type":53,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100453653","phase-1-triplex-checkpoint-inhibitors-therapy-for-advanced-solid-tumors-100453653",false,"NCT05187338","Triplex Checkpoint Inhibitors Therapy for Advanced Solid Tumors","Triplex CTLA4\u002FPD1\u002FPDL1 Checkpoint Inhibitors Combination Therapy for Advanced Solid Tumors","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","70 Years",{"count":65,"type":66},100,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE1","PHASE2","This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by infusion of CTLA4, PD1 and PDL1 antibodies combination through venous (IV), artery (IA) or intra-tumor (IT).",[73,74,75,76,77,78,79,80,81,82,83],"Lung Cancer","Liver Cancer","Colorectal Cancer","Pancreas Cancer","Ovary Cancer","Head and Neck Cancer","Breast Cancer","Gastric Cancer","Cervical Cancer","Esophageal Cancer","Sarcoma",[85,86,87,88,89,90,91],"Solid tumor","CTLA4 antibody","PD1 antibody","PDL1 antibody","Interventional Radiology","Trans-artery infusion","Intra-tumor injection","2024-06-23",{"date":94,"type":95},"2024-06-25","ACTUAL",{"date":97,"type":95},"2021-11-01",{"date":99,"type":66},"2035-10-30",{"name":5,"class":6},1]