[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100551702":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":35,"responsibleParty":50,"collaborators":20,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":54,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Tumor-infiltrating Lymphocytes Therapy","EXPERIMENTAL","Autologous Tumor-infiltrating Lymphocytes Therapy, 2.0\\*10\\^7\u002FKg, single intravenous infusion.",[13],"Procedure: Autologous Tumor-infiltrating Lymphocytes",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"PROCEDURE","Autologous Tumor-infiltrating Lymphocytes","Autologous Tumor-infiltrating Lymphocytes, 2.0\\*10\\^7\u002FKg, single intravenous infusion.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Junliang Fu, PhD, MD","the Fifth Medical Center of PLA","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","86-10-66933214","fjunliang@163.com",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Fu-Sheng Wang, PhD, MD","86-10-66933328","fswang302@163.com",[36],{"facility":24,"status":37,"city":38,"state":20,"zip":20,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Beijing","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48,49],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},{"type":51,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100551702","phase-1-safety-and-efficacy-of-autologous-tumor-infiltrating-lymphocytes-therapy-in-patients-with-hepatocellular-carcinoma-100551702",false,"NCT06463522","Safety and Efficacy of Autologous Tumor-infiltrating Lymphocytes Therapy in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Aged 18 to 70 years;\n2. Diagnosis of HCC with BCLC stage B\u002FC;\n3. Anticipated survival time is longer than 3 months;\n4. Liver function grade Child-Pugh A or B, without hepatic encephalopathy;\n5. Left ventricular ejection fraction (LVEF) ≥ 50%;\n6. ECOG physical status 0-2;\n7. Laboratory tests at baseline meet the following: Absolute neutrophil count \\>1.0 x 109\u002FL; Absolute neutrophil count \\>1.0 x 109\u002FL; White blood cell count \\> 2.0 x 109\u002FL; Platelet count \\> 60 x 109\u002FL; Hgb \\> 8.0 g\u002FdL; ALT and AST ≤ 5 times the upper limit of normal (ULN), Serum total bilirubin (TBiL) ≤ 51 mmol\u002FL, or \\\u003C 3 times the ULN.\n8. Female subjects of childbearing potential must take acceptable measures to minimize the likelihood of pregnancy during the trial. Female subjects of childbearing potential must have a negative serum or urine pregnancy result within 48 hours prior to treatment;\n9. Able to receive treatment and follow-up, including the need for the subject to receive treatment at the enrollment center.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women;\n2. WIth HIV\u002FAIDS infection;\n3. Active infection with a temperature \\>38.3°C prior to study treatment and have been treated with antibiotics within 2 weeks prior to enrollment;\n4. Presence of the following pre-existing or concomitant diseases: Prior diagnosis of a severe autoimmune disease requiring systemic immunosuppression (steroids) for a prolonged period of time (more than 2 months), or immune-mediated symptomatic disease; Prior diagnosis of autoimmune-induced motor neuron disease; Prior toxic epidermal necrolysis release; Subjects with any psychiatric condition, including dementia, altered mental status, which may interfere with treatment in this study; Subjects with other malignancies in the previous 5 years; Subjects with heart failure ≥ grade 2 (NYHA) or hypertension uncontrolled by standard therapy; Subjects with unstable or active peptic ulcer or gastrointestinal bleeding; Subjects with serious uncontrollable disease, as determined by the study, that may interfere with treatment in this study;\n5. Subjects undergoing treatment with systemic steroids;\n6. Subjects who have previously used immune cell therapy (CIK, DC, DC-CIK, LAK therapy) and are less than 28 days from the end of treatment to screening;\n7. Subjects who are allergic to cell therapy products or related drugs;\n8. Subjects who have previously received an organ transplant or are planning to receive an organ transplant;\n9. Subjects requiring anticoagulant therapy (warfarin or heparin);\n10. Subjects who are judged by the investigator to be unsuitable for participation in this study due to other conditions.","ALL","18 Years","70 Years",{"count":62,"type":63},20,"ESTIMATED","INTERVENTIONAL",[66,67],"PHASE1","PHASE2","This is a Phase 1, open label clinical trial of tumor-infiltrating lymphocytes for the treatment of patients with hepatocellular carcinoma. The purpose of this study is to assess the safety of tumor-infiltrating lymphocytes therapy in patients with hepatocellular carcinoma.",[70],"Hepatocellular Carcinoma",[70,72],"Tumor-infiltrating Lymphocytes","2024-08-11",{"date":75,"type":76},"2024-08-13","ACTUAL",{"date":78,"type":76},"2024-07-01",{"date":80,"type":63},"2026-07-01",{"name":5,"class":6},1]