[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491803":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":28,"locations":33,"responsibleParty":58,"collaborators":19,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":19,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":19,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":19,"overallStatus":35,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Beijing Konruns Pharmaceutical Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KC1036","EXPERIMENTAL","60mg QD",[13],"Drug: KC1036",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Patients take 60mg QD of KC1036 for the efficacy and safety study. KC1036 are given orally once daily, 21 days as a cycle.",[9],null,[21,25],{"name":22,"affiliation":23,"role":24},"Yongsheng Wang, Ph.D","West China Hospital","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Wentao Fang, Ph.D","Shanghai Chest Hospital",[29],{"name":22,"role":30,"phone":31,"phoneExt":19,"email":32},"CONTACT","18980602258","Wangys75@gmail.com",[34,48],{"facility":27,"status":35,"city":36,"state":37,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"RECRUITING","Shanghai","Shanghai Municipality","China","CN",{"type":41,"coordinates":42},"Point",[43,44],121.45806,31.22222,{"lat":44,"lon":43},[47],{"name":26,"role":30,"phone":19,"phoneExt":19,"email":19},{"facility":23,"status":35,"city":49,"state":50,"zip":19,"country":38,"countryCode":39,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Chengdu","Sichuan",{"type":41,"coordinates":52},[53,54],104.06667,30.66667,{"lat":54,"lon":53},[57],{"name":22,"role":30,"phone":19,"phoneExt":19,"email":19},{"type":59,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100491803","phase-2-a-study-of-kc1036-in-patients-with-advanced-thymic-tumors-100491803",false,"NCT05683886","A Study of KC1036 in Patients with Advanced Thymic Tumors","A Single-arm, Open, Multicenter, Phase II Study to Evaluate the Efficacy and Safety of KC1036 in the Patients with Advanced Recurrent or Metastatic Thymic Tumors","Inclusion Criteria:\n\n* Patients with thymoma or thymic carcinoma confirmed by cytologically or histologically (WHO Classification of Thoracic Tumors 5th ed), including all pathological subtypes;\n* Patients with advanced recurrent, unresectable and\u002For metastatic thymic tumor as defined by the Masaoka-Koga stage;\n* Subsequent relapse of disease following first-line systemic chemotherapy;\n* Patients with at least one measurable lesion as defined by RECIST V1.1; Measurable lesions located within the radiation field of previous radiotherapy or after local treatment can also be selected as target lesions if progression is confirmed.\n* Eastern Cooperative Oncology Group performance status score of 0 or 1;\n* Life expectancy \\> 12 weeks;\n* Adequate organ and marrow function;\n* Patients should participate in the study voluntarily and sign informed consent.\n\nExclusion Criteria:\n\n* Patients with thymus neuroendocrine tumors;\n* Any patient who is known to have central nervous system (CNS) metastasis or imaging shows a risk of CNS metastasis;\n* Previous (within the last 5 years) or current malignancies at other sites;\n* Gastrointestinal abnormalities;\n* Cardiovascular and cerebrovascular diseases;\n* Patients who have previous treatment with small molecule VEGFR-TKI (except patients whose treatment cycle is less than 2 weeks due to intolerance or other reasons); Patients who have previous treatment with PD-1 \u002F PD-L1 antibody combined with small molecule VEGFR-TKI;\n* Involved in other clinical trials within 4 weeks before enrollment; Prior anti-tumor therapies with chemotherapy, cytotherapy, immunotherapy, operation (Interventional therapy excepted) within 4 weeks 4 weeks before enrollment; Prior radiotherapy (palliative radiotherapy excepted) within 2 weeks; Prior small-molecule targeted therapy within 2 weeks or 5 half-lives.\n* Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE V5.0 grade 0 or 1 with the exception of alopecia;\n* Skin wound, surgical site, wound site, mucous membrane severe ulcer or fracture comfirmed as having not recovered;\n* Uncontrolled mass pleural effusion, ascites, and pericardial effusion;\n* Active autoimmune diseases: Myasthenia gravis, pure red cell aplastic anemia, systemic lupus erythematosus, inflammatory bowel disease, etc;\n* Need immunosuppressive agents or hormone therapy for immunosuppression, , and still need immunosuppressive therapy within 2 weeks before enrollment;\n* Active bacterial, viral or fungal infection; Fever of unknown cause (\\> 38.5℃) occurred within 2 weeks before enrollment;\n* Patients who are positive for both Hepatitis B surface antigen (HBsAg) and hepatitis B virus deoxyribonucleic acid (HBV-DNA) quantification results; Patients who are positive for both hepatitis C virus antibody (HCAB) and hepatitis C virusribonucleic acid (HCV-RNA) quantification results; Patients who are positive for human immunodeficiency virus (HIV);\n* Pregnant or lactating women;\n* Patients who do not take contraception during the study period and within 6 months after the study;\n* Patients with insufficient compliance as evaluated by investigator;\n* The investigator believes that it is not suitable to patient in this clinical trial.","ALL","18 Years","75 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This is a single arm，open-label, multicentric, phase II study to evaluate the efficacy and safety of KC1036 in patients with advanced recurrent or metastatic thymoma or thymic carcinoma.",[78],"Thymic Tumors","2024-10-15",{"date":81,"type":82},"2024-10-17","ACTUAL",{"date":84,"type":82},"2023-02-22",{"date":86,"type":72},"2026-02",{"name":5,"class":6},2]