[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100473618":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":20,"responsibleParty":21,"collaborators":23,"id":27,"slug":28,"hasResults":29,"nctId":30,"briefTitle":31,"officialTitle":32,"acronym":20,"eligibilityCriteria":33,"healthyVolunteers":29,"sex":34,"minAge":35,"maxAge":36,"enrollmentInfo":37,"targetDuration":20,"studyType":40,"phases":41,"briefSummary":43,"conditions":44,"keywords":47,"overallStatus":49,"whyStopped":20,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":20},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TCRX-T","EXPERIMENTAL","① 1x10\\^7\u002Fm2 ;\n\n* 3x10\\^7\u002Fm2；\n\n  * 1x10\\^8\u002Fm2；\n\n    * 3x10\\^8\u002Fm2；\n\n      * 1x10\\^9\u002Fm2。",[13],"Biological: Tcrx T cell",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Tcrx T cell","Sequential IV infusion",[9],null,{"type":22,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[24],{"name":25,"class":26},"TCRx Therapeutics Co.Ltd","INDUSTRY","100473618","early-phase-1-tcrxt-cells-for-advanced-or-recurrent-gastricgastroesophageal-junction-cancer-after-failure-of-first-chemotherapy-100473618",false,"NCT05447234","TCRx_T Cells for Advanced or Recurrent Gastric\u002FGastroesophageal Junction Cancer After Failure of First Chemotherapy","Exploratory Clinical Study of TCRx_T Cells in the Treatment of Advanced or Recurrent Gastric\u002FGastroesophageal Junction Cancer After Failure of First Chemotherapy","Inclusion Criteria:\n\n1. Age 18-70 years old;\n2. Histologically confirmed advanced\u002Flocally advanced or metastatic gastric cancer at the stomach or gastroesophageal junction, progressed after first-line chemotherapy, or recurrence after gastric\u002Fgastroesophageal junction surgery combined with neoadjuvant\u002Fadjuvant chemotherapy\n3. Expected survival time ≥ 3 months\n4. Eastern Cooperative Oncology Group (ECOG) score 0-2\n5. According to the Response Evaluation Criteria for Solid Tumors (RECIST 1.1), at least one one-dimensional, measurable tumor (short-axis diameter greater than 1 cm)\n6. Normal bone marrow hematopoietic function: (leukocytes≥4000 cells\u002F㎕, neutrophils≥1500 cells\u002F㎕, platelet counts≥100000 cells\u002F㎕)\n7. Normal liver and kidney function: serum bilirubin \\\u003C1.5mg\u002Fdl, AST (SGOT) and ALT (SGPT) \\\u003C2.5UNL, alkaline phosphatase \\\u003C5UNL; serum creatinine \\\u003C1.5mg\u002Fdl;\n8. Men and women must take appropriate contraceptive measures.\n\nExclusion Criteria:\n\n1. Patients with previous non-gastric\u002Fgastroesophageal junction malignant tumor\n2. History of severe acute allergy\n3. There is an uncontrolled infection\n4. History or clinical evidence of central nervous system (CNS) metastasis or leptomeningeal carcinomatosis\n5. History of cerebrovascular accident within the past 6 months, including transient ischemic attack (TIA), pulmonary embolism or untreated deep vein thrombosis (DVT)\n6. History of one or more of the following cardiovascular diseases within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass grafting, symptomatic peripheral vascular disease , NYHA type III or IV congestive heart failure\n7. Poor control of hypertension\n8. QT interval \\>480ms\n9. Evidence of active bleeding or bleeding tendency\n10. Clinically significant gastrointestinal abnormalities, such as bleeding, obstruction, and high risk of perforation\n11. Grade 3 or 4 diarrhea\n12. Any serious and\u002For unstable previous medical, psychiatric, or other circumstances that may affect subject safety, provide informed consent, or comply with research procedures\n13. Unable or unwilling to stop using illicit drugs for at least 14 days or drug half-life (whichever is longer) before and during the first study drug administration\n14. Treated with any of the following anticancer therapies: radiotherapy, tumor embolization or chemotherapy, immunotherapy, biological therapy within 14 days before the first dose; neoadjuvant chemotherapy or adjuvant chemotherapy must be at least 6 months before the start of the study Finish\n15. Any persistent toxicity greater than grade 1 and\u002For worsening in severity from prior anticancer therapy, except for alopecia\n16. Participate in a clinical trial of another investigational drug within 30 days prior to the start of the study\n17. Pregnant or lactating women\n18. Men or women planning to become pregnant within the next six months","ALL","18 Years","70 Years",{"count":38,"type":39},50,"ESTIMATED","INTERVENTIONAL",[42],"EARLY_PHASE1","To observe and determine the safety, tolerability, cellular pharmacokinetics and efficacy of TCRx T cells in patients with advanced or recurrent gastric\u002Fgastroesophageal junction cancer after failure of first chemotherapy.",[45,46],"Gastric Cancer","Gastroesophageal-junction Cancer",[48,45,46],"T Cell Receptor","NOT_YET_RECRUITING","2023-02-14",{"date":52,"type":53},"2023-02-16","ACTUAL",{"date":55,"type":39},"2023-03-01",{"date":57,"type":39},"2028-03-01",{"name":5,"class":6}]