[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513091":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":37,"centralContacts":54,"locations":62,"responsibleParty":77,"collaborators":37,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":37,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":37,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":37,"overallStatus":65,"whyStopped":37,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Akeso","INDUSTRY",[8,16,21,27],{"label":9,"type":10,"description":11,"interventionNames":12},"Part 1 cohort 1","EXPERIMENTAL","Subjects receive cadonilimab combination chemotherapy(SOX) neoadjuvant therapy 3 cycles.",[13,14,15],"Drug: Cadonilimab","Drug: Oxaliplatin","Drug: Tegafur-gimeracil-oteracil potassium",{"label":17,"type":10,"description":18,"interventionNames":19},"Part 1 cohort 2","Subjects receive cadonilimab combination chemotherapy(SOX) and AK117 neoadjuvant therapy 3 cycles.",[13,20,14,15],"Drug: AK117",{"label":22,"type":10,"description":23,"interventionNames":24},"Part 2 cohort 1","Subjects receive cadonilimab combination chemotherapy(FLOT) neoadjuvant therapy 4 cycles.",[13,14,25,26],"Drug: Docetaxel","Drug: 5-Fluorouracil",{"label":28,"type":10,"description":29,"interventionNames":30},"Part 2 cohort 2","Subjects receive cadonilimab combination chemotherapy(FLOT) and AK117 neoadjuvant therapy 4 cycles.",[13,20,14,25,26],[32,38,41,44,48,51],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Cadonilimab","IV infusion,Specified dose on specified days",[9,17,22,28],null,{"type":33,"name":39,"description":35,"armGroupLabels":40,"otherNames":37},"AK117",[17,28],{"type":33,"name":42,"description":35,"armGroupLabels":43,"otherNames":37},"Oxaliplatin",[9,17,22,28],{"type":33,"name":45,"description":46,"armGroupLabels":47,"otherNames":37},"Tegafur-gimeracil-oteracil potassium","Oral,Specified dose on specified days",[9,17],{"type":33,"name":49,"description":35,"armGroupLabels":50,"otherNames":37},"Docetaxel",[22,28],{"type":33,"name":52,"description":35,"armGroupLabels":53,"otherNames":37},"5-Fluorouracil",[22,28],[55,60],{"name":56,"role":57,"phone":58,"phoneExt":37,"email":59},"Weifeng Song, MD","CONTACT","+86(0760)89873999","clinicaltrials@akesobio.com",{"name":61,"role":57,"phone":37,"phoneExt":37,"email":37},"Han Liang, MD",[63],{"facility":64,"status":65,"city":66,"state":37,"zip":37,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Tianjin Provincial Tumor Hospital","RECRUITING","Tianjin","China","CN",{"type":70,"coordinates":71},"Point",[72,73],117.17667,39.14222,{"lat":73,"lon":72},[76],{"name":61,"role":57,"phone":37,"phoneExt":37,"email":37},{"type":78,"investigatorFullName":37,"investigatorTitle":37,"investigatorAffiliation":37,"oldNameTitle":37,"oldOrganization":37},"SPONSOR","100513091","phase-2-cadonilimab-combination-with-chemotherapy-with-or-without-ak117-in-resectable-gastric-or-gastroesophageal-junction-adenocarcinoma-100513091",false,"NCT05960955","Cadonilimab Combination With Chemotherapy With or Without AK117 in Resectable Gastric or Gastroesophageal Junction Adenocarcinoma","Phase II Clinical Study of Cadonilimab Combination With Chemotherapy With or Without the Anti-CD47 Antibody AK117 Neoadjuvant\u002FAdjuvant Therapy for Resectable Gastric or Gastroesophageal Junction Adenocarcinoma","Inclusion Criteria:\n\n* Be able and willing to provide written informed consent.\n* 18 to 75 years old.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has a histologically confirmed diagnosis of Gastric or Gastroesophageal Junction Adenocarcinoma(G\u002FGEJ).\n* Has Stage T3-4N+M0 G\u002FGEJ (American Joint Committee on Cancer \\[AJCC\\])\n* Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Has adequate organ function.\n\nExclusion Criteria:\n\n* Are there suspected metastases or locally advanced, unresectable disease, regardless of disease stage.\n* Is currently participating in a study of an investigational agent or using an investigational device.\n* Has undergone major surgery within 30 days of Study Day 1.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected).\n* History of myocardial infarction, unstable angina, congestive heart failure within 12 months prior to day 1 of study treatment.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n* Has received a live virus vaccine within 30 days of the planned first dose of study therapy.","ALL","18 Years","75 Years",{"count":90,"type":91},90,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","This trial is a Phase II study. All patients are resectable Gastric or Gastroesophageal Junction Adenocarcinoma, Eastern Cooperative Oncology Group (ECOG) performance status 0-1.The purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy with or without AK117 neoadjuvantin treatment of resectable Gastric or Gastroesophageal Junction Adenocarcinoma.",[97],"Resectable Gastric or Gastroesophageal Junction Adenocarcinoma","2023-11-15",{"date":100,"type":101},"2023-11-18","ACTUAL",{"date":103,"type":101},"2023-11-13",{"date":105,"type":91},"2027-11-30",{"name":5,"class":6},1]