[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"biological-therapy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:biological-therapy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"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":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29],"Gastric (Stomach) Cancer","Biological Therapy","Immunotherapy",[31,32,33,34,35],"Gastric cancer","late-stage","progression-free survival","chemotherapy","T cell biological therapy","RECRUITING","2025-10-02",{"date":39,"type":40},"2025-10-08","ACTUAL",{"date":42,"type":40},"2025-07-01",{"date":44,"type":21},"2028-06-30",{"name":46,"class":47},"Chinese PLA General Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":48},"100577673","phase-4-a-cohort-study-on-biomarkers-to-predict-the-efficacy-of-biologics-for-chronic-rhinosinusitis-with-nasal-polyps-100577673","NCT06801353","A Cohort Study on Biomarkers to Predict the Efficacy of Biologics for Chronic Rhinosinusitis with Nasal Polyps","Inclusion Criteria:\n\n1. Age 18-75 years old.\n2. With bilateral chronic rhinosinusitis with nasal polyposis.\n3. Nasal Polyp Score ≥4 (minimum score of 2 per nasal cavity) at baseline.\n4. Nasal congestion score ≥2 at baseline.\n5. Patients who have received systemic corticosteroids (SCS) treatment within 2 years before screening, and\u002For have contraindications or intolerance to SCS treatment, and\u002For received surgical for nasal polyps more than 6 months before screening.\n6. Have been using intranasal corticosteroids (INCS) at a stable dose for at least 4 weeks before screening.\n7. Symptoms of nasal obstruction and additional symptoms such as loss of smell or rhinorrhea should be present for at least 4 weeks before screening.\n8. Good adherence.\n\nExclusion Criteria:\n\n1. Not enough washing out period for prior biological therapy (within 10 weeks or 5 half-lives \\[whichever is longer\\] before baseline).\n2. Use of systemic immunosuppressants for inflammatory diseases or autoimmune diseases within 8 weeks or 5 half-lives before baseline (whichever is longer).\n3. Initiation of leukotriene receptor antagonist treatment, oral glucocorticoid treatment, or traditional Chinese medicine treatment for chronic rhinosinusitis within 4 weeks before baseline.\n4. Subjects who have undergone surgery that changed the nasal structure and cannot be evaluated for Nasal Polyp Score.\n5. Participants with a forced expiratory volume in 1 second (FEV1) ≤50% of predicted normal during screening\u002Frun-in period.\n6. Hypersensitivity to MFNS or anti-IL-4R monoclonal antibodies or stapokibart components.\n7. Concomitant with other poorly controlled serious diseases or recurrent chronic diseases.\n8. Women who are pregnant, breastfeeding, or planning either during the study.","75 Years",{"count":20,"type":21},[58],"PHASE4","Recently, several biologic therapies have become available for treating chronic rhinosinusitis with nasal polyps (CRSwNP). However, not every patient responds to these treatments. This clinical trial aims to develop a non-invasive predictive model to help determine how effective IL-4Rα targeted monoclonal antibody therapy will be for individuals with CRSwNP.",[61,28,62],"Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)","Biomarkers","NOT_YET_RECRUITING","2025-02-05",{"date":66,"type":40},"2025-02-06",{"date":68,"type":21},"2025-02-01",{"date":70,"type":21},"2026-07-01",{"name":72,"class":47},"Beijing Tongren Hospital"]