[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554028":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":28,"interventions":58,"overallOfficials":21,"centralContacts":21,"locations":81,"responsibleParty":102,"collaborators":21,"id":104,"slug":21,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":21,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":21,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":84,"whyStopped":21,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":21},[9,13],{"measure":10,"description":11,"timeFrame":12},"ORR","Objective response rate","12 months",{"measure":14,"description":15,"timeFrame":12},"Safety and tolerability","Safety and tolerability assessed by incidence and severity of adverse events",[17],{"measure":18,"description":19,"timeFrame":20},"PFS","The efficacy end points","24 months",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"NON_RANDOMIZED","SINGLE_GROUP","TREATMENT",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE",[29,36,41,44,47,50,55],{"label":30,"type":31,"description":21,"interventionNames":32},"SSGJ-707(dose 1)+ XELOX","EXPERIMENTAL",[33,34,35],"Drug: SSGJ-707","Drug: Oxaliplatin","Drug: Capecitabine",{"label":37,"type":31,"description":21,"interventionNames":38},"SSGJ-707(dose 1)+ mFOLFOX6",[33,34,39,40],"Drug: Calcium Folinate","Drug: 5-fluorouracil",{"label":42,"type":31,"description":21,"interventionNames":43},"SSGJ-707(dose 2)+ XELOX",[33,34,35],{"label":45,"type":31,"description":21,"interventionNames":46},"SSGJ-707(dose 2)+ mFOLFOX6",[33,34,39,40],{"label":48,"type":31,"description":21,"interventionNames":49},"SSGJ-707+XELOX\u002FmFOLFOX6",[33,34,35,39,40],{"label":51,"type":52,"description":21,"interventionNames":53},"Bevacizumab+XELOX\u002FmFOLFOX6","ACTIVE_COMPARATOR",[54,34,35,39,40],"Drug: Bevacizumab",{"label":56,"type":31,"description":21,"interventionNames":57},"SSGJ-707 monotherapy",[33],[59,64,68,72,75,78],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":21},"DRUG","SSGJ-707","bispecific antibody",[56,30,37,42,45,48],{"type":60,"name":65,"description":66,"armGroupLabels":67,"otherNames":21},"Bevacizumab","VEGF antibody",[51],{"type":60,"name":69,"description":70,"armGroupLabels":71,"otherNames":21},"Oxaliplatin","chemotherapy",[51,30,37,42,45,48],{"type":60,"name":73,"description":70,"armGroupLabels":74,"otherNames":21},"Capecitabine",[51,30,42,48],{"type":60,"name":76,"description":70,"armGroupLabels":77,"otherNames":21},"Calcium Folinate",[51,37,45,48],{"type":60,"name":79,"description":70,"armGroupLabels":80,"otherNames":21},"5-fluorouracil",[51,37,45,48],[82],{"facility":83,"status":84,"city":85,"state":86,"zip":21,"country":87,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Liu Tianshu","RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":90,"coordinates":91},"Point",[92,93],121.45806,31.22222,{"lat":93,"lon":92},[96,101],{"name":97,"role":98,"phone":99,"phoneExt":21,"email":100},"Liu Tianshu, PhD","CONTACT","13681973996","liu.tianshu@zs-hospital.sh.cn",{"name":97,"role":98,"phone":21,"phoneExt":21,"email":21},{"type":103,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100554028",false,"NCT06493760","A Phase 2 Study of SSGJ-707 in Metastatic Colorectal Cancer Patients","A Phase 2 Study to Evaluate the Safety and Efficacy of SSGJ-707 As First-Line Treatment in Metastatic Colorectal Cancer Patients","Inclusion Criteria:\n\n1. Males and\u002For females over age 18\n2. Histologically and\u002For cytologically documented metastatic colorectal cancer confirmed .\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n4. Expected survival \\>=12 weeks.\n5. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Known uncontrolled or symptomatic central nervous system metastatic disease.\n2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \\>1 (National Cancer Institute Common terminology Criteria \\[NCI CTCAE\\] v.5.0).\n3. Inadequate organ or bone marrow function.\n4. Pregnant or breast-feeding woman.\n5. Known allergies, hypersensitivity, or intolerance to SSGJ-707 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","18 Years","75 Years",{"count":114,"type":115},130,"ESTIMATED","INTERVENTIONAL",[118],"PHASE2","This study includes two parts:Part 1: SSGJ-707 (different dosing regimens) in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.Part 2: SSGJ-707 in combination with chemotherapy versus bevacizumab in combination with chemotherapy for first-line treatment of metastatic colorectal cancer.",[121],"Metastatic Colorectal Cancer",[61,123],"colorectal cancer","2024-09-04",{"date":126,"type":127},"2024-09-19","ACTUAL",{"date":129,"type":127},"2024-09-03",{"date":131,"type":115},"2027-06",{"name":5,"class":6},1]