[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499883":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":61,"collaborators":11,"id":63,"slug":11,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":11,"enrollmentInfo":71,"targetDuration":11,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":11,"overallStatus":49,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Peking University Cancer Hospital & Institute","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Three-drug arm","EXPERIMENTAL",null,[13],"Drug: camrelizumab+apatinib+TMZ",{"label":15,"type":16,"description":11,"interventionNames":17},"Two-drug arm","ACTIVE_COMPARATOR",[18],"Drug: camrelizumab+apatinib",{"label":20,"type":16,"description":11,"interventionNames":21},"single-drug arm",[22],"Drug: camrelizumab",[24,29,33],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"DRUG","camrelizumab+apatinib+TMZ","camrelizumab 200mg，q2w+apatinib 250mg，qd+TMZ 200mg\u002Fm2，day1-5\u002F28",[9],{"type":25,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"camrelizumab+apatinib","camrelizumab 200mg，q2w+apatinib 250mg qd",[15],{"type":25,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"camrelizumab","camrelizumab 200mg，q2w",[20],[38],{"name":39,"affiliation":5,"role":40},"Jun Guo, Dr","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":11,"email":45},"CONTACT","010-88121122","guoj307@126.com",[47],{"facility":48,"status":49,"city":50,"state":11,"zip":11,"country":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Beijing Cancer Hospital","RECRUITING","Beijing","China",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59],{"name":60,"role":43,"phone":11,"phoneExt":11,"email":45},"Jun Guo",{"type":40,"investigatorFullName":60,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Chief physician","100499883",false,"NCT05789043","Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma","Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma: a Multicenter, Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n* age:≥18 years, male or female.\n* Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III\u002FIV).\n* Has not received any systematic anti-tumor drug treatment.\n* Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.\n* ECOG 0-1.\n* Adequate organ function.\n* Life expectancy of greater than 12 weeks.\n* Patient has given written informed consent.\n\nExclusion Criteria:\n\n* Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.\n* Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation.\n* Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);\n* Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \\> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;\n* Received a live vaccine within 4 weeks before the first dose of study medication.\n* Pregnancy or breast feeding.\n* Decision of unsuitableness by principal investigator or physician-in charge.","ALL","18 Years",{"count":72,"type":73},140,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.",[79],"Acral Melanoma","2023-09-04",{"date":82,"type":83},"2023-09-06","ACTUAL",{"date":85,"type":83},"2023-03-21",{"date":87,"type":73},"2027-02-15",{"name":5,"class":6},1]