[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615612":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":29,"studyPopulation":29,"armGroups":36,"interventions":47,"overallOfficials":53,"centralContacts":58,"locations":64,"responsibleParty":75,"collaborators":77,"id":81,"slug":29,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":29,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":29,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":29,"overallStatus":99,"whyStopped":29,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Shanghai Juncell Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Adverse Events","To characterize the safety profile of GC101 TIL in patients with pancreatic ductal adenocarcinoma who were failed to standard treatment as assessed by incidence of adverse events.","6 month",[14,18,20,23,26],{"measure":15,"description":16,"timeFrame":17},"Objective Response Rate (ORR)","Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)","Up to 36 months",{"measure":19,"description":16,"timeFrame":17},"Disease Control Rate (DCR）",{"measure":21,"description":22,"timeFrame":17},"Duration of Response (DOR)","The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1",{"measure":24,"description":25,"timeFrame":17},"Progression-Free Survival (PFS)","The time from TIL infusion until disease progression or death from any cause.",{"measure":27,"description":28,"timeFrame":17},"Overall Survival(OS)","The time from TIL infusion until death from any cause.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":29,"primaryPurpose":33,"observationalModel":29,"timePerspective":29,"maskingInfo":34},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":29,"whoMasked":29},"NONE",[37,43],{"label":38,"type":39,"description":40,"interventionNames":41},"Arm B","EXPERIMENTAL","GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[42],"Biological: GC101TIL",{"label":44,"type":39,"description":45,"interventionNames":46},"Arm A","GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[42],[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":29},"BIOLOGICAL","GC101TIL","A tumor sample is resected from each participant and cultured ex vivo to expand the population of Autologous Tumor Infiltrating Lymphocytes Injection (GC101 TIL). After lymphodepletion, patients are infused GC101 TIL.",[44,38],[54],{"name":55,"affiliation":56,"role":57},"Huangming Hong","Sichuan Cancer Hospital & Institute, Sichuan Cancer Center","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":29,"email":63},"Ying Cheng","CONTACT","+8621-69110327","ying.cheng@juncell.com",[65],{"facility":56,"status":29,"city":66,"state":29,"zip":29,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":29},"Chengdu","China","CN",{"type":70,"coordinates":71},"Point",[72,73],104.06667,30.66667,{"lat":73,"lon":72},{"type":76,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[78],{"name":79,"class":80},"Sichuan Cancer Hospital and Research Institute","OTHER","100615612",false,"NCT07294872","A Study of TIL in Advanced Solid Tumors (CZ)","A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101\u002F203 TIL) in Patients With Advanced Solid Tumors","Inclusion Criteria:\n\n* have one the tumor resection for TILs production and successfully produced；\n* Age: 18 years to 75years;\n* Histologically diagnosed as solid tumors;\n* Expected life-span more than 3 months;\n* ECOG score 0-1;\n* Test subjects have failed standard treatment regimens, and be willing to receive TIL therapy;\n* At least 1 evaluable tumor lesion;\n\nExclusion Criteria:\n\n* with other malignant tumors, except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \\\u003C 95%;\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and\u002For anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n* Significant cardiovascular anomalies","ALL","18 Years","70 Years",{"count":91,"type":92},30,"ESTIMATED","INTERVENTIONAL",[95],"PHASE1","This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.",[98],"Solid Tumor, Adult","NOT_YET_RECRUITING","2026-01-15",{"date":102,"type":103},"2026-01-16","ACTUAL",{"date":105,"type":92},"2026-05-08",{"date":107,"type":92},"2029-09-20",{"name":5,"class":6},1]