[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648143":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":39,"locations":11,"responsibleParty":45,"collaborators":11,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":11,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":11,"enrollmentInfo":56,"targetDuration":11,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":11,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":11},{"fullName":5,"class":6},"Qilu Pharmaceutical Co., Ltd.","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"QLS31905+Oxaliplatin+Capecitabine","EXPERIMENTAL",null,[13,14,15],"Drug: QLS31905","Drug: Oxaliplatin","Drug: Capecitabine",{"label":17,"type":18,"description":11,"interventionNames":19},"Sintilimab+Oxaliplatin+Capecitabine","ACTIVE_COMPARATOR",[20,14,15],"Drug: Sintilimab",[22,27,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","QLS31905","QLS31905 will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Sintilimab","Sintilimab will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.",[17],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Oxaliplatin","Oxaliplatin will be administered every 3 weeks Intravenous infusion on day 1 of each cycle.",[9,17],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"Capecitabine","Capecitabine will be administered orally twice daily (bid).",[9,17],[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Lin Shen, PhD","CONTACT","010-88196358","doctorshenlin@sina.cn",{"type":46,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648143","phase-3-qls31905-in-combination-with-capox-versus-sintilimab-in-combination-with-capox-as-first-line-treatment-in-patients-with-gcgej-100648143",false,"NCT07716449","QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With GC\u002FGEJ","A Randomized, Open-label, Multicenter Phase III Clinical Study of QLS31905 in Combination With CAPOX Versus Sintilimab in Combination With CAPOX as First-line Treatment in Patients With Unresectable Locally Advanced or Metastatic CLDN18.2-positive, PD-L1 CPS \u003C 5 Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Subjects voluntarily participate in the study and sign the informed consent form;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;\n* Expected survival time ≥ 12 weeks;\n* Histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma;\n* No prior systemic anti-tumor treatment for unresectable locally advanced or metastatic disease;\n* At least one measurable lesion per RECIST v1.1;\n* Patients with adequate cardiac, liver, renal function, etc.\n\nExclusion Criteria:\n\n* Known history of allergy to any component of the study drug;\n* Other second primary malignant neoplasm within 5 years;\n* Significant cardiovascular and cerebrovascular disorders within 6 months before randomization;\n* Haemorrhage requiring haemostatic treatment within 3 months prior to randomisation;\n* Previous or current interstitial pneumonia, pulmonary fibrosis, pneumoconiosis, etc;\n* Previous treatment targeting CLDN18.2;\n* Patients with added risks associated with the study or may interfere with the interpretation of study results as determined by the investigator, or deemed unsuitable by the investigator.","ALL","18 Years",{"count":57,"type":58},560,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","This study is a randomized, open, multicenter phase III clinical study designed to compare the efficacy and safety of QLS31905 injection combined with CAPOX versus sintilimab combined with CAPOX in the first-line treatment of CLDN18.2 positive, PD-L1 CPS \\\u003C 5 unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.",[64],"Gastric or Gastroesophageal Junction Adenocarcinoma","NOT_YET_RECRUITING","2026-07-16",{"date":68,"type":69},"2026-07-21","ACTUAL",{"date":71,"type":58},"2026-08",{"date":73,"type":58},"2029-08",{"name":5,"class":6}]