[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100383864":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":19,"locations":20,"responsibleParty":42,"collaborators":19,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":19,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":19,"enrollmentInfo":53,"targetDuration":19,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":19,"overallStatus":23,"whyStopped":19,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"Shanghai Changzheng Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anlotinib Plus Toripalimab","EXPERIMENTAL","the combination of Anlotinib Plus Toripalimab as first-line treatment",[13],"Drug: Anlotinib Plus Toripalimab",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w",[9],null,[21],{"facility":22,"status":23,"city":24,"state":19,"zip":19,"country":25,"countryCode":26,"cosmosGeoPoint":27,"geoPoint":32,"contacts":33},"Department of Medical Oncology, Shanghai Changzheng Hospital","RECRUITING","Shanghai","China","CN",{"type":28,"coordinates":29},"Point",[30,31],121.45806,31.22222,{"lat":31,"lon":30},[34,39],{"name":35,"role":36,"phone":37,"phoneExt":19,"email":38},"Ke Liu","CONTACT","+86-18502113721","45352126@qq.com",{"name":40,"role":41,"phone":19,"phoneExt":19,"email":19},"Yuan-Sheng Zang","PRINCIPAL_INVESTIGATOR",{"type":41,"investigatorFullName":40,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Director","100383864","phase-2-anlotinib-plus-toripalimab-as-first-line-treatment-for-advanced-gastric-cancer-with-ecog-2-apical-gc-100383864",false,"NCT04278222","Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)","Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial","Inclusion Criteria:\n\n* Histologically confirmed, UICC stage IV gastric cancer;\n* no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;\n* at least one measurable lesion;\n* received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;\n* ECOG performance status 2;\n* the main organ function to meet the following criteria: HB ≥ 90g \u002F L, ANC ≥ 1.5 × 109 \u002F L, PLT ≥ 80 × 109 \u002F L,BIL \\\u003C1.5 times the upper limit of normal (ULN), ALT and AST \\\u003C2.5 × ULN and if liver metastases, BIL \\\u003C 3 × ULN, ALT and AST \\\u003C5 × ULN; Serum Cr ≤ 1.5 × ULN;\n* Patient's written declaration of consent obtained;\n* Estimated life expectancy \\> 3 months;\n\nExclusion Criteria:\n\n* harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;\n* dMMR\u002FMSI-H;\n* Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);\n* have received anlotinib or other immune checkpoint inhibitor ;\n* with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;\n* severe wounds or surgery 4 weeks before recruitment;\n* received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;\n* History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.\n* pregnancy or breast feeding;\n* absent or restricted legal capacity;\n* a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study","ALL","18 Years",{"count":54,"type":55},24,"ESTIMATED","INTERVENTIONAL",[58],"PHASE2","This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.",[61,62,63,64],"Gastric Cancer","Immunotherapy","Anlotinib","Toripalimab","2024-07-09",{"date":67,"type":68},"2024-07-10","ACTUAL",{"date":70,"type":68},"2020-02-10",{"date":72,"type":55},"2024-12-31",{"name":5,"class":6},1]