[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509868":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":42,"locations":48,"responsibleParty":68,"collaborators":28,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":28,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":28,"enrollmentInfo":81,"targetDuration":28,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":51,"whyStopped":28,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Renmin Hospital of Wuhan University","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemoradiation + Tislelizumab","EXPERIMENTAL","Intensity-modulated radiotherapy (IMRT):\n\nEsophageal primary tumor: 39.6Gy\u002F2.2Gy Bone metastasis: 30Gy\u002F3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy\u002F3Gy\n\nDuring concurrent radiation therapy:\n\nDrug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 75 mg\u002Fm² IV QW Drug: Cisplatin 25 mg\u002Fm² IV QW\n\nDuring consolidation therapy:\n\nDrug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg\u002Fm² IV Q3W Drug: Cisplatin 75 mg\u002Fm² IV Q3W",[13,14,15,16],"Radiation: Intensity-modulated radiotherapy (IMRT)","Drug: Tislelizumab","Drug: Cisplatin","Drug: Nab paclitaxel",{"label":18,"type":19,"description":20,"interventionNames":21},"Chemotherapy + Tislelizumab","ACTIVE_COMPARATOR","Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg\u002Fm² IV Q3W Drug: Cisplatin 75 mg\u002Fm² IV Q3W",[14,15,16],[23,29,34,38],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"RADIATION","Intensity-modulated radiotherapy (IMRT)","Esophageal primary tumor: 39.6Gy\u002F2.2Gy Bone metastasis: 30Gy\u002F3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy\u002F3Gy",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Tislelizumab","200 mg IV Q3W",[9,18],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":28},"Cisplatin","During concurrent radiation therapy: 25 mg\u002Fm² IV QW During consolidation therapy: 75 mg\u002Fm² IV Q3W",[9,18],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":28},"Nab paclitaxel","During concurrent radiation therapy: 75 mg\u002Fm² IV QW During consolidation therapy: 220 mg\u002Fm² IV Q3W",[9,18],[43],{"name":44,"role":45,"phone":46,"phoneExt":28,"email":47},"Yongshun Chen, MD","CONTACT","+86 15327122084","yongshun2007@163.com",[49],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Renmin hosptial of Wuhan University","RECRUITING","Wuhan","Hubei","430060","China","CN",{"type":58,"coordinates":59},"Point",[60,61],114.26667,30.58333,{"lat":61,"lon":60},[64],{"name":65,"role":45,"phone":66,"phoneExt":28,"email":67},"Liwei Chen","86+15671578311","wdrmiit@163.com",{"type":69,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Yongshun Chen","Professor","100509868","phase-3-a-study-of-chemoradiation-in-combination-with-tislelizumab-as-first-line-treatment-in-participants-with-advanced-esophageal-squamous-cell-carcinoma-100509868",false,"NCT05919030","A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma","Chemoradiation Versus Chemotherapy in Combination with Tislelizumab As First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma with Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial","Inclusion Criteria:\n\n1. Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition).\n2. Subjects must have unresectable advanced, recurrent or metastatic ESCC.\n3. Subjects must not be amenable to curative approaches such as definitive chemoradiation and\u002For surgery.\n4. PD-L1 expression (CPS) is less than 10.\n5. No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.\n6. ECOG Performance Status of 0 or 1.\n7. Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization.\n8. Subjects must have adequate organ and bone marrow function.\n\nExclusion Criteria:\n\n1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.\n2. Active known or suspected autoimmune disease.\n3. Any serious or uncontrolled medical disorder or active infection.\n4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).\n5. Any positive test result for hepatitis B or C indicating acute or chronic infection and\u002For detectable virus.\n6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.","ALL","18 Years",{"count":82,"type":83},155,"ESTIMATED","INTERVENTIONAL",[86],"PHASE3","This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.",[89],"Esophageal Squamous Cell Carcinoma",[91,92,93,94,95],"Chemoradiation","Immunotherapy","Advanced esophageal cancer","Low PD-L1 expression","Progression-free survival","2024-11-12",{"date":98,"type":99},"2024-11-14","ACTUAL",{"date":101,"type":99},"2023-07-01",{"date":103,"type":83},"2027-07-01",{"name":5,"class":6},1]