[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565985":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":32,"studyPopulation":32,"armGroups":39,"interventions":50,"overallOfficials":32,"centralContacts":58,"locations":68,"responsibleParty":87,"collaborators":32,"id":89,"slug":32,"hasResults":90,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":32,"eligibilityCriteria":94,"healthyVolunteers":90,"sex":95,"minAge":96,"maxAge":97,"enrollmentInfo":98,"targetDuration":32,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":32,"overallStatus":71,"whyStopped":32,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Shanghai Hengrui Pharmaceutical Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Overall Survival","Measure description: Defined as time from randomization until the date of death due to any cause","Until death, assessed up to approximately 2 years",[14,18,22,25,28],{"measure":15,"description":16,"timeFrame":17},"Progression-free survival (PFS) by investigator assessment","Measure description: Defined as time from randomization until progression or death as assessed by the investigator","Until progression or death, assessed up to approximately 1 year",{"measure":19,"description":20,"timeFrame":21},"Objective response rate (ORR) by investigator assessment","Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator","Until progression, assessed up to approximately 1 year",{"measure":23,"description":24,"timeFrame":17},"Duration of response (DOR) by investigator assessment","Measure description: Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator",{"measure":26,"description":27,"timeFrame":21},"Disease control rate (DCR) by investigator assessment","Measure description: Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator",{"measure":29,"description":30,"timeFrame":31},"Incidence and severity of adverse events (AEs)\u002Fserious adverse events (SAEs)","Measure description: Incidence and severity of adverse events (AEs)\u002Fserious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0","until to 90 days after the last dose，assessed up to approximately 2 years",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":32,"primaryPurpose":36,"observationalModel":32,"timePerspective":32,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":32,"whoMasked":32},"NONE",[40,45],{"label":41,"type":42,"description":32,"interventionNames":43},"Treatment group A: SHR-A1904","EXPERIMENTAL",[44],"Drug: SHR-A1904",{"label":46,"type":47,"description":32,"interventionNames":48},"Treatment group B: Paclitaxel, Docetaxel, Irinotecan.","ACTIVE_COMPARATOR",[49],"Drug: Paclitaxel, Docetaxel, Irinotecan",[51,55],{"type":52,"name":53,"description":53,"armGroupLabels":54,"otherNames":32},"DRUG","SHR-A1904",[41],{"type":52,"name":56,"description":56,"armGroupLabels":57,"otherNames":32},"Paclitaxel, Docetaxel, Irinotecan",[46],[59,64],{"name":60,"role":61,"phone":62,"phoneExt":32,"email":63},"Qi Shi","CONTACT","86-021-23511999","shi.qi.qs16@hengrui.com",{"name":65,"role":61,"phone":66,"phoneExt":32,"email":67},"Liang Hu","18036618148","Liang.hu@hengrui.com",[69],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Sun Yat-sen University Cancer Center","RECRUITING","Guangzhou","Guangdong","510060","China","CN",{"type":78,"coordinates":79},"Point",[80,81],113.25,23.11667,{"lat":81,"lon":80},[84],{"name":85,"role":86,"phone":32,"phoneExt":32,"email":32},"Ruihua Xu","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100565985",false,"NCT06649292","SHR-A1904 Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patitens With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","An Open, Randomized,Positive Control, Multicenter Phase III Clinical Study of SHR A1904 for Injection Compared With Investigator's Choice of Therapy in Claudin18.2 Positive Patients With Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n1. Age 18 to 75 years old (including boundary values)\n2. Volunteer to participate in this clinical study and sign informed consent;\n3. ECOG score 0-1;\n4. Expected survival ≥3 months;\n5. Gastric or Gastroesophageal Junction Adenocarcinoma;\n6. positive CLDN18.2 expression in tumor tissue;\n7. There is at least one measurable or evaluable lesion that meets the RECIST 1.1 criteria;\n8. Adequate bone marrow and organ function.\n\nExclusion Criteria:\n\n1. Received anti-tumor therapies such as chemotherapy, radiotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks before the first dose of the study\n2. HER2 posotive (IHC 3+ or IHC 2+\u002FISH +);\n3. Toxicities caused by previous anticancer therapy were not recovered to CTCAE 5.0 Grade≤1;\n4. Individuals with Leptomeningeal metastasis or Active brain metastases;\n5. Individuals with a history of GI perforation or fistula, unstable GI bleeding;\n6. Individuals with a history of severe cardiovascular and cerebrovascular diseases;\n7. The researcher determined that there are other situations that are not suitable for participation.","ALL","18 Years","75 Years",{"count":99,"type":100},524,"ESTIMATED","INTERVENTIONAL",[103],"PHASE3","The study evaluated the overall survival (OS) of SHR-A1904 versus investigator-selected treatment in second-line CLDN18.2-positive advanced GC\u002FGEJC patients",[106],"Second-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma","2026-05-12",{"date":109,"type":110},"2026-05-15","ACTUAL",{"date":112,"type":110},"2024-11-22",{"date":114,"type":100},"2028-03-20",{"name":5,"class":6},1]