[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531049":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":42,"centralContacts":47,"locations":52,"responsibleParty":68,"collaborators":27,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":27,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":27,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":27,"overallStatus":55,"whyStopped":27,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Beijing Konruns Pharmaceutical Co., Ltd.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"KC1036","EXPERIMENTAL","KC1036 will be administrated.",[13],"Drug: KC1036",{"label":15,"type":16,"description":17,"interventionNames":18},"Investigator's choice of chemotherapy","ACTIVE_COMPARATOR","Irinotecan, Docetaxel or S-1 will be administrated.",[19,20,21],"Drug: Irinotecan","Drug: Docetaxel","Drug: S-1",[23,28,32,36],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","KC1036 60mg QD orally, before a meal, continuous administration, 21 days as a cycle",[9],null,{"type":24,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Irinotecan","Irinotecan intravenously administered at 130-150 mg\u002Fm2 once every 2 weeks",[15],{"type":24,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Docetaxel","Docetaxel intravenously administered at 60-75 mg\u002Fm2 once every 3 weeks；",[15],{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"S-1","S-1 orally administered 40-60mg Bid on Day 1 to Day 14 of every 3 weeks, 21 days as a cycle",[15],[41],"Tegafur-gimeracil-oteracil potassium",[43],{"name":44,"affiliation":45,"role":46},"Jing Huang, Ph.D","Cancer Institute and Hospital, Chinese Academy of Medical Sciences","PRINCIPAL_INVESTIGATOR",[48],{"name":44,"role":49,"phone":50,"phoneExt":27,"email":51},"CONTACT","010-87788293","huangjingwg@163.com",[53],{"facility":54,"status":55,"city":56,"state":27,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","100021","China","CN",{"type":61,"coordinates":62},"Point",[63,64],116.39723,39.9075,{"lat":64,"lon":63},[67],{"name":44,"role":49,"phone":50,"phoneExt":27,"email":51},{"type":69,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100531049","phase-3-a-study-of-kc1036-versus-investigators-choice-of-chemotherapy-in-patients-with-advanced-esophageal-cancer-100531049",false,"NCT06194734","A Study of KC1036 Versus Investigator's Choice of Chemotherapy in Patients With Advanced Esophageal Cancer","A Randomized, Controlled, Open-label, Multicenter Phase III Study to Evaluate the Efficacy and Safety of KC1036 Versus Investigator's Choice of Chemotherapy as Third-line Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Males or females aged 18 to 75 years;\n* Histologically or cytologically confirmed esophageal or esophageal-gastric junction squamous cell carcinoma;\n* Patient with advanced recurrent or metastatic esophageal squamous cell carcinoma previously treated with a PD-1 or PD-L1 inhibitor and at least second-line systemic therapy;\n* At least one measurable tumor lesion according to RECIST 1.1;\n* Eastern Cooperative Oncology Group performance status score of 0 or 1;\n* Life expectancy \\> 12 weeks;\n* BMI≥16.0 and weight≥40 kg ;\n* Adequate bone marrow, renal, and hepatic function;\n* Female patients of childbearing potential with a negative blood pregnancy test completed within 7 days before randomization；\n* Patients should participate in the study voluntarily and sign informed consent.\n\nExclusion Criteria:\n\n* Any patient who is known to have untreated central nervous system (CNS) metastasis;\n* Other kinds of malignancies within 5 years;\n* Gastrointestinal abnormalities;\n* Cardiovascular and cerebrovascular diseases;\n* Prior therapies with vascular targeting inhibitor；\n* Previously treated with Irinotecan, Docetaxel and Tegafur Gimeracil Oteracil Potassium；\n* Involved in other clinical trials within 4 weeks before enrollment；Prior anti-tumor therapies with radiotherapy, immunotherapy, operation within 4 weeks before enrollment;Prior anti-tumor therapies with small molecule targeting drugs within 2weeks or 5 half-lives (whichever is longer) before enrollment; Prior anti-tumor therapies with chemotherapy within 3 weeks or 5 half-lives (whichever is longer) before enrollment;\n* Presence of unresolved toxicities from prior anti-tumor therapy, defined as having not resolved to NCI CTCAE 5.0 Grade 0 or 1;\n* Uncontrolled massive ascites, pleural or pericardial effusion;\n* Severe infection within 4 weeks prior to randomization (CTCAE \\> Grade 2);\n* Known history of human immunodeficiency virus (HIV) infection or current active hepatitis B or C infection;\n* Pregnant or lactating women;\n* Female subjects of child-bearing potential and male subjects of reproductive capacity who do not agree to use contraceptive measures during the study and for 6 months after the end of the study.\n* Other patients are not eligible for enrollment assessed by investigators.","ALL","18 Years","75 Years",{"count":81,"type":82},490,"ESTIMATED","INTERVENTIONAL",[85],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of KC1036 versus investigator's choice of chemotherapy in patients with advanced recurrent or metastatic esophageal squamous cell carcinoma",[88],"Esophageal Squamous Cell Carcinoma","2024-03-06",{"date":91,"type":92},"2024-03-07","ACTUAL",{"date":94,"type":92},"2024-02-05",{"date":96,"type":82},"2027-12-30",{"name":5,"class":6},1]