[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100343753":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":57,"collaborators":35,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":35,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":35,"enrollmentInfo":68,"targetDuration":35,"studyType":71,"phases":72,"briefSummary":75,"conditions":76,"keywords":87,"overallStatus":43,"whyStopped":35,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Pembrolizumab via localized infusion","EXPERIMENTAL","This group dividied into two subgroups:\n\n1. Checkpoint inhibitor (CPI) such as Pembrolizumab ± Ipilimumab is administrated with a dose of 1-2mg\u002Fkg via sustained (10min) micro-pump infusion via artery, plus chemotherapy, every 3 weeks.\n2. Checkpoint inhibitor (CPI) such as Pembrolizumab ± Ipilimumab is administrated with a total dose of 150mg via intra-tumor fine needle injection in 5 min, plus doxorubicin, every 3 weeks.",[13],"Drug: Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Checkpoint inhibitor (CPI) Pembrolizumab plus chemotherapy via vein infusion","ACTIVE_COMPARATOR","Checkpoint inhibitor (CPI) such as Pembrolizumab is administrated with a total dose of 2mg\u002Fkg via vein infusion (30 min), plus chemotherpy every 3 weeks.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Checkpoint inhibitor (CPI) such as Pembrolizumab plus chemotherapy","vein, artery, or intra-tumor infusion of checkpoint inhibitor (CPI) such as Pembrolizumab and\u002For Ipilimumab, plus chemotherapy to destroy cancer cells and release tumor antigen for improving CPI therapeutic efficacy.",[15,9],[26],"Checkpoint inhibitor (CPI) such as Keytruda plus chemotherapy",[28],{"name":29,"affiliation":5,"role":30},"Zhenfeng Zhang, MD,PhD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},"CONTACT","02034153532",null,"zhangzhf@gzhmu.edu.cn",{"name":38,"role":33,"phone":34,"phoneExt":35,"email":39},"Deji Chen, MD,PhD","chendeji2003@163.com",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The Second Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guanzhou","Guangdong","51260","China","CN",{"type":50,"coordinates":51},"Point",[52,53],113.37117,23.06828,{"lat":53,"lon":52},[56],{"name":29,"role":33,"phone":34,"phoneExt":35,"email":36},{"type":58,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100343753","phase-2-trans-arteryintra-tumor-infusion-of-checkpoint-inhibitors-plus-chemodrug-for-immunotherapy-of-advanced-solid-tumors-100343753",false,"NCT03755739","Trans-Artery\u002FIntra-Tumor Infusion of Checkpoint Inhibitors Plus Chemodrug for Immunotherapy of Advanced Solid Tumors","A Phase II\u002FIII Trial of Comparison of Benefit of Administration of Checkpoint Inhibitors Plus Chemodrug Via Artery or Fine Needle to Tumor Versus Vein for Immunotherapy of 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",{"count":69,"type":70},200,"ESTIMATED","INTERVENTIONAL",[73,74],"PHASE2","PHASE3","This trial was designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by trans-artery\u002Fintra-tumor infusion of PD1\u002FPDL1 antibody and\u002For CTLA4 antibody ipilimumab plus chemotherapeutic drug and to compare their differences.",[77,78,79,80,81,82,83,84,85,86],"Hepatocarcinoma","Lung Cancer","Melanoma","Renal Cancer","Head and Neck Cancer","Pancreas Cancer","Ovarian Cancer","Colo-rectal Cancer","Cervical Cancer","Breast Cancer",[88,89,90,91,92],"Solid cancers","Check-point inhibitors","Interventional Radiology","Trans-artery infusion","Intra-tumor injection","2024-06-22",{"date":95,"type":96},"2024-06-25","ACTUAL",{"date":98,"type":96},"2018-11-01",{"date":100,"type":70},"2036-11-01",{"name":5,"class":6},1]