[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100450999":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":31,"collaborators":33,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":20,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":20,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":20,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":20},{"fullName":5,"class":6},"Women's Hospital School Of Medicine Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TILs infusion","EXPERIMENTAL","Enrolled patients will be infused with their autologous TILs followed by IL-2 administration after post- NMA lymphodepletion",[13],"Biological: Autologous tumor-infiltrating lymphocytes",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Autologous tumor-infiltrating lymphocytes","Fresh tumor samples will be resected from enrolled patients. Autologous TILs will be extracted and reinfused to corresponding patients after ex vivo stimulation, activation and extensive expansion.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Hui Wang, MD","PRINCIPAL_INVESTIGATOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Songfa Zhang, MD","CONTACT","+86(571)89992145","zhangsongfa@zju.edu.cn",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[34,36,38],{"name":35,"class":6},"Tongji Hospital",{"name":37,"class":6},"Qilu Hospital of Shandong University",{"name":39,"class":6},"Sun Yat-sen University","100450999","phase-1-efficacy-and-safety-of-tils-in-treatment-of-patients-with-advanced-or-metastatic-refractory-gynecological-cancer-100450999",false,"NCT05152797","Efficacy and Safety of TILs in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer","Efficacy and Safety of Autologous Tumor-infiltrating Lymphocytes in Treatment of Patients With Advanced or Metastatic Refractory Gynecological Cancer: a Prospective Multicenter One-arm Phase Ⅱ Trial","Inclusion Criteria:\n\nParticipants eligible for inclusion in this study must meet all of the following criteria: Signed informed consent must be obtained prior to participation in the study.\n\n* Aged 18-75 years old at the time of consent\n* Participants are diagnosed with advanced or metastatic cervical cancer, ovarian cancer, endometrial cancer or breast cancer with radiology and pathology confirmation.\n* Failure of two or more Lines of Chemotherapy, or not amenable to curative treatment.\n* At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to extract TIL\n* At least one measurable target lesion, that can be accurately measured in at least one dimension with longest diameter ≥20 mm, as defined by RECIST v1.1\n* All the chemotherapy or radiotherapy targeting the malignant tumors must be discontinued at least 28 days prior to the tumor resection.\n* No serious abnormality of complete blood count and Cardiac, Liver, and Kidney function\n\nExclusion Criteria:\n\n* Participants who have received organ transplantation or prior cell transfer therapy\n* Any active autoimmune disease or history of autoimmune disease, or history of primary immunodeficiency.\n* Patients who are taking systemic steroid therapy\n* Patients with confirmed HIV infection, or other uncontrolled active viral infections, or serious system infections\n* Patients with serious complications of heart, lung, liver, kidney, not suitable for enrollment.\n* Patients with suspicious or confirmed brain metastases of any size and any number.\n* Suffered from any other malignancy within 5 years (except for fully treated in situ malignant such as breast cancer, bladder cancer, cutaneous basal cell carcinoma or squamous cell carcinoma)\n* Patients who are pregnant or breastfeeding\n* Any other conditions judged by the researcher will significantly increase the risk of participation.","FEMALE","18 Years","75 Years",{"count":51,"type":52},91,"ESTIMATED","INTERVENTIONAL",[55,56],"PHASE1","PHASE2","Prospective, multicenter, single-arm, open label, interventional basket trial to evaluate autologous tumor-infiltrating lymphocytes (TILs) infusion followed by IL-2 after a non-myeloablative (NMA) lymphodepletion preparation for the treatment of patients with advanced or metastatic refractory gynecological cancer including cervical, ovarian, endometrial and breast carcinoma.",[59],"Tumor Infiltrating Lymphocytes","NOT_YET_RECRUITING","2021-11-28",{"date":63,"type":64},"2021-12-10","ACTUAL",{"date":66,"type":52},"2022-01-01",{"date":68,"type":52},"2026-12-31",{"name":5,"class":6}]