[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549289":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":20,"responsibleParty":27,"collaborators":20,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":20,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":20,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":20,"overallStatus":50,"whyStopped":20,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":20},{"fullName":5,"class":6},"First Affiliated Hospital of Wenzhou Medical University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Neoantigen Reactive T Cells","EXPERIMENTAL","Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory;nab-paclitaxel 100-200mg\u002Fm2\u002FD will be i.v. for 7 days before cell infusion; Cyclophosphamide 300mg\u002Fm2\u002FD will be i.v. for 2 and 3 days before cell infusion; NRTs 0.5\\~1 x 10\\^10, will be i.v.Q3 weeks for total 4 doses;Interleukin-2 (IL-2) will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 1000,000 international unit per day.All Patients will receive a total of 4 cycles of treatment.",[13],"Biological: Neoantigen Reactive T Cells(NRTs)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Neoantigen Reactive T Cells(NRTs)","Neoantigen Reactive T Cells in an expected volume of 100 milliliter（mL） will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Xian Shen","CONTACT","13968888872","13968888872@163.com",{"type":28,"investigatorFullName":29,"investigatorTitle":30,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Shen Xian","Chief Physician","100549289","early-phase-1-neoantigen-reactive-t-cells-c-for-chinese-patients-with-advanced-gastric-cancer-100549289",false,"NCT06432075","Neoantigen Reactive T Cells c for Chinese Patients With Advanced Gastric Cancer","Single Arm Clinical Prospective Study of Neoantigen Reactive T Cells (NRTs) in the Treatment of Chinese Patients With Advanced Gastric Cancer","Inclusion Criteria:\n\n1. Voluntarily join the study and sign the informed consent;\n2. Age: 18-75 years old, male or female;\n3. Subjects with advanced gastric cancer who had received systematic standard treatment before enrollment and had no effective treatment at present. (Note: The effective treatment means refer to the latest version of the \"Gastric Cancer Diagnosis and Treatment Guide\" issued by China's \"Chinese Clinical Oncology Society\".) ;\n4. Have at least one measurable lesion according to imRECIST evaluation criteria;\n5. Expected survival ≥5 months (starting from the collection of tissue samples for sequencing);\n6. The Eastern Cancer Consortium (ECOG) score was 0 or 1 or 2;\n7. The following hematological indicators should be met: neutrophil count ≥ 1.5×109\u002FL; Hemoglobin ≥ 10.0 g\u002FdL; Platelet count ≥ 50×109\u002FL;\n8. The following biochemical indicators should be met: total bilirubin ≤2.0× upper limit of normal value (ULN); AST and ALT ≤2.0×ULN; Serum creatinine ≤1.5×ULN.\n9. Before lymphocyte clearance preadministration: 1) any chemotherapy, small molecule targeted drugs and other antitumor therapy received have passed the 3-week washout period, and the toxic side effects have returned to grade 1 or lower (excluding hair loss, vitiligo and other events as determined by the investigator to be tolerated); 2) If surgical treatment is performed within 3 weeks, toxicity has returned to grade 1 or lower; 3) The immunotoxicity of major organs has returned to grade 1 or lower after receiving any antibody drug treatment, and the washout period of PD-1 antibodies has reached 6 weeks, and CTLA-4 antibodies and other antibodies have passed the washout period of 4 weeks.\n\nExclusion Criteria:\n\n1. Subjects infected with HBV, HCV, HIV, syphilis and tuberculosis;\n2. Uncontrolled coronary artery disease or asthma, uncontrolled cerebrovascular disease or what the investigator considers Other diseases not included in the group;\n3. Patients with a history of bone marrow or organ transplantation; Patients with coagulation dysfunction;\n4. Patients with immune deficiency diseases or autoimmune diseases who are treated with immunosuppressive drugs;\n5. Central nervous system (CNS) metastatic and\u002For cancerous meningitis;\n6. People who may be allergic to immunotherapy;\n7. Drug abuse, clinical or psychological or social factors that affect informed consent or the conduct of the study;\n8. Pregnant and lactating women;\n9. Participating in other clinical trials;\n10. An uncertainty that the investigator believes has an impact on the subject's safety or compliance.","ALL","18 Years","75 Years",{"count":42,"type":43},20,"ESTIMATED","INTERVENTIONAL",[46],"EARLY_PHASE1","The purpose of this study is to see the safety and efficient of neoantigen reactive T cells (NRTs) in the treatment of Chinese patients with advanced gastric cancer.",[49],"Advanced Gastric Cancer","NOT_YET_RECRUITING","2024-05-22",{"date":53,"type":54},"2024-05-29","ACTUAL",{"date":56,"type":43},"2024-06-01",{"date":58,"type":43},"2026-12-01",{"name":5,"class":6}]