[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552824":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":23,"locations":32,"responsibleParty":48,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":71,"conditions":72,"keywords":76,"overallStatus":34,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Second Affiliated Hospital of Guangzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"IRSW-MIM","EXPERIMENTAL",null,[13],"Device: IRSW-MIM",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DEVICE","IRSW-MIM collects patient's data and outputs a therapeutical strategy for treating advanced solid tumors.",[9],[20],{"name":21,"affiliation":5,"role":22},"Zhenfeng Zhang, MD, PhD","PRINCIPAL_INVESTIGATOR",[24,28],{"name":21,"role":25,"phone":26,"phoneExt":11,"email":27},"CONTACT","+862039195966","zhangzhf@gzhmu.edu.cn",{"name":29,"role":25,"phone":30,"phoneExt":11,"email":31},"Bingjia He, MD","+862039195965","464677938@qq.com",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":11,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Guangzhou","Guangdong","China","CN",{"type":40,"coordinates":41},"Point",[42,43],113.25,23.11667,{"lat":43,"lon":42},[46],{"name":47,"role":25,"phone":26,"phoneExt":11,"email":27},"Zhang Zhenfeng, MD, PhD",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[51],{"name":52,"class":53},"Immuno (Guangzhou) Biomedicine S&T Ltd","UNKNOWN","100552824","phase-2-interventional-software-for-multi-immunotherapy-of-solid-tumors-100552824",false,"NCT06478108","Interventional Software for Multi-immunotherapy of Solid Tumors","Interventional Software IRSW-MIM Guided Immunotherapy for Advanced Solid Tumors: a Phase II Clinical Trial.","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":65,"type":66},60,"ESTIMATED","INTERVENTIONAL",[69,70],"PHASE2","PHASE3","This trial is designed to investigate the safety, response rates and survival outcomes of patients with advanced solid tumors by intra-tumor (IT) injection of multiple drugs including CTLA4, PD1, and\u002For PDL1 antibodies combined with drugs-eluting beads loaded with IL2, chemodrug, anti-angiogenesis drug, et. al that will be recommended by an AI-based medical software named IRSW-MIM developed by a cooperating company.",[73,74,75],"Lung Cancer","Liver Cancer","Solid Tumor, Adult",[77,78,79,80,81],"Solid Tumor","Medical device","Software","Immunotherapy","Interventional radiology","2024-06-23",{"date":84,"type":85},"2024-06-27","ACTUAL",{"date":87,"type":85},"2024-04-01",{"date":89,"type":66},"2033-12-30",{"name":5,"class":6},1]