[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609311":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":58,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":83,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"TAS-102+RAK cell","EXPERIMENTAL","Combined therapy of RAK cells and TAS-102",[13,14],"Biological: RetroNectin active Killer cells","Drug: TAS-102 (trifluridine and tipiracil, Lonsurf®)",{"label":16,"type":17,"description":18,"interventionNames":19},"TAS-102","ACTIVE_COMPARATOR","sole use of TAS-102",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","RetroNectin active Killer cells","RetroNectin-Activated Killer (RAK) cells, derived from autologous peripheral blood mononuclear cells (PBMCs), are induced in vitro by RetroNectin along with anti-CD3 monoclonal antibody and Interleukin-2 (IL-2). These cells consist of various cytotoxic effectors, primarily CD8+ T (cytotoxic T, Tc) cells and natural killer T cells, which exhibit minimal cytotoxicity to normal cells but substantial specificity to tumor cells, thereby demonstrating both safety and potent anti-tumor activity.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","TAS-102 (trifluridine and tipiracil, Lonsurf®)","Based on the results of the RECOURSE \\[16\\] and TERRA \\[17\\] studies, TAS-102 (Trifluridine\u002FTipiracil Hydrochloride) will be administered orally at a dose of 35mg\u002Fm², twice daily, Days 1-5, with each cycle lasting 3 weeks.",[16,9],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"HongYi Liu, Prof.","CONTACT","86-010-66937523","yunhe_gao301@163.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"The First＆Fifth Medical Center of Chinese PLA General Hospital","RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":26,"email":57},"Jiang Cao, Dr.","86-010-66937166","301irb@sina.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Lin Chen","Prof.","100609311","phase-2-the-safety-and-clinical-efficacy-of-rak-cell-therapy-in-late-stage-gastric-cancer-a-randomized-controlled-trial-100609311",false,"NCT07212933","The Safety and Clinical Efficacy of RAK Cell Therapy in Late-stage Gastric Cancer: A Randomized Controlled Trial","RAK in GC","Inclusion Criteria:\n\n* 1\\. Subjects voluntarily join this study and sign the informed consent form. 2. Age ≥18 years and ≤70 years. 3. Confirmed by gastroscopic pathology or imaging (enhanced CT\u002FPET-CT) as Stage IV gastric cancer or gastroesophageal junction adenocarcinoma (cTanyNanyM1). Metastatic sites include but are not limited to: liver, peritoneum, lungs, pancreas, greater omentum, retroperitoneal lymph nodes, etc.\n\n  4\\. Failure or disease progression after prior frontline anti-tumor therapy (including ineffective first- and second-line chemotherapy, targeted therapy, and immunotherapy for advanced gastric cancer).\n\n  5\\. Have measurable solid tumors (efficacy evaluation standard: RECIST 1.1); tumor assessment via CT scan or MRI must be performed within 28 days before treatment.\n\n  6\\. Physical performance status ECOG 0-3. 7. Expected lifespan ≥1 month. 8. Participants must be able to understand the study procedures and agree to participate in the study by providing written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Concurrent other types of malignancy. 2. Severe cardiac, pulmonary, or cerebral system diseases. 3. Expected survival \\\u003C1 month. 4. Laboratory investigations indicating unsuitability for receiving anti-tumor biotherapy:\n\n  1. Moderate to severe bone marrow suppression: (HGB \\\u003C80 g\u002FL; WBC \\\u003C2.0×10⁹\u002FL; ANC \\\u003C1.0×10⁹\u002FL; PLT \\\u003C50×10⁹\u002FL).\n  2. Significantly decreased liver function (Child-Pugh Grade C).\n  3. Severe renal insufficiency (CKD Stage III and above).\n  4. Severe coagulation dysfunction (INR ≥1.5 or APTT \\>1.5 × ULN).","ALL","18 Years","70 Years",{"count":73,"type":74},90,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","This project employs a prospective, double-blind, randomized controlled trial methodology to comparatively analyze the safety and survival outcomes of human umbilical cord blood RAK cells applied in advanced gastric cancer. Firstly, the maximum tolerated dose (MTD) of RAK cell therapy for patients with advanced gastric cancer will be determined through a dose-escalation trial. Subsequently, the overall survival (OS), progression-free survival (PFS), and incidence of adverse events will be compared between the RAK treatment group and the control group. This aims to explore the efficacy and safety of biotherapy for recurrent or metastatic gastric cancer where frontline therapy has failed, thereby laying the foundation and providing evidence for large-scale, multi-center clinical studies.",[80,81,82],"Gastric (Stomach) Cancer","Biological Therapy","Immunotherapy",[84,85,86,87,88],"Gastric cancer","late-stage","progression-free survival","chemotherapy","T cell biological therapy","2025-10-02",{"date":91,"type":92},"2025-10-08","ACTUAL",{"date":94,"type":92},"2025-07-01",{"date":96,"type":74},"2028-06-30",{"name":5,"class":6},1]