[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629929":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":43,"locations":49,"responsibleParty":66,"collaborators":27,"id":68,"slug":27,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":27,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":27,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":27,"overallStatus":52,"whyStopped":27,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Beijing Konruns Pharmaceutical Co., Ltd.","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase IIa (Dose Escalation and Expansion)","EXPERIMENTAL","This is a multicenter, single-arm, dose-escalation and expansion phase. Subjects will receive KC1036 at one of three dose levels (20 mg QD, 30 mg QD, or 40 mg QD) in combination with fixed doses of Toripalimab and platinum-based chemotherapy (Paclitaxel and Cisplatin).",[13,14,15,16],"Drug: KC1036","Drug: Toripalimab","Drug: Paclitaxel","Drug: Cisplatin",{"label":18,"type":10,"description":19,"interventionNames":20},"Phase IIb (Randomized Expansion)","This is a multicenter, randomized, parallel-group, open-label phase. Based on Phase IIa results, 2-3 dose cohorts will be selected. Subjects will be randomized (1:1 or 1:1:1) to receive the assigned dose of KC1036 in combination with Toripalimab and platinum-based chemotherapy.",[14,15,16,13],[22,28,32,36,40],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","KC1036","Dosage: 20 mg, 30 mg, or 40 mg; Route: Oral; Frequency: Once daily (QD) under fasting conditions (at least 2 hours before and 1 hour after dosing), 21 days as a cycle.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Toripalimab","Dosage: 240 mg; Route: Intravenous (IV) infusion; Frequency: Every 3 weeks (Q3W) on Day 1 of each 21-day cycle, for up to 2 years.",[9,18],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Paclitaxel","Dosage: 175 mg\u002Fm2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.",[9,18],{"type":23,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Cisplatin","Dosage: 60-75 mg\u002Fm2; Route: IV infusion; Frequency: Day 1 of each 21-day cycle, for a maximum of 6 cycles.",[9,18],{"type":23,"name":24,"description":41,"armGroupLabels":42,"otherNames":27},"Dosage: Selected doses from Phase IIa (20 mg, 30 mg, or 40 mg); Route: Oral; Frequency: Once daily (QD) under fasting conditions, 21 days as a cycle.",[18],[44],{"name":45,"role":46,"phone":47,"phoneExt":27,"email":48},"Jing Huang, Ph.D","CONTACT","+86-010-87788293","huangjingwg@163.com",[50],{"facility":51,"status":52,"city":53,"state":27,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Cancer Hospital, Chinese Academy of Medical Sciences","RECRUITING","Beijing","100021","China","CN",{"type":58,"coordinates":59},"Point",[60,61],116.39723,39.9075,{"lat":61,"lon":60},[64],{"name":45,"role":46,"phone":65,"phoneExt":27,"email":48},"010-87788293",{"type":67,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100629929",false,"NCT07481058","KC1036 in Combination With PD-1 Antibody and Platinum-based Chemotherapy for First-line Advanced Esophageal Cancer","A Phase II Clinical Study to Evaluate the Efficacy and Safety of KC1036 Combined With PD-1 Antibody and Platinum-based Chemotherapy as First-line Treatment for Advanced Recurrent or Metastatic 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* Patients who have not received prior systemic anti-tumor therapy for the current recurrent or metastatic disease;\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 kg\u002Fm2;\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 the first dose;\n* Patients should participate in the study voluntarily and sign informed consent.\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressing central nervous system (CNS) metastasis;\n* Other malignancies within the past 5 years;\n* Known hypersensitivity to any monoclonal antibodies or chemotherapy components;\n* Gastrointestinal abnormalities;\n* High risk of bleeding or fistula due to tumor invasion of adjacent organs, or existing esophageal\u002Ftracheal fistula;\n* Cardiovascular and cerebrovascular diseases;\n* Prior therapy with anti-angiogenic drugs or immunotherapy; Systemic therapy, investigational drugs, or live vaccines within 4 weeks prior to the first dose; Palliative radiotherapy within 2 weeks or major surgery within 28 days prior to enrollment;\n* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage;\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* Active autoimmune disease or a history of autoimmune disease requiring systemic treatment;\n* Active infections, including severe infection (CTCAE \\> Grade 2) within 4 weeks, active tuberculosis, or positive status for HIV, HBV, or HCV;\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 conditions assessed by the investigator that would increase safety risks or interfere with the study results.","ALL","18 Years","75 Years",{"count":78,"type":79},60,"ESTIMATED","INTERVENTIONAL",[82],"PHASE2","The purpose of this study is to evaluate the efficacy and safety of KC1036 in combination with PD-1 antibody and platinum-based chemotherapy as a first-line treatment for patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC).",[85],"Esophageal Squamous Cell Carcinoma (ESCC)","2026-03-18",{"date":88,"type":89},"2026-03-20","ACTUAL",{"date":91,"type":89},"2025-12-12",{"date":93,"type":79},"2028-12",{"name":5,"class":6},1]