[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100535776":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Toripalimab+CCRT","EXPERIMENTAL","External beam radiotherapy (EBRT) of 45-50.4Gy was delivered using intensity modulated radiation therapy (IMRT) technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg\u002Fm2 by intravenous infusion, was administered once a week for 5 weeks during EBRT.\n\nToripalimab 240mg by intravenous infusion was administered every 3 weeks for 6 months and maintained upto 2 years for those whose lesions did not reach complete remission at six-month follow-up.",[13,14],"Drug: Toripalimab","Radiation: CCRT",{"label":16,"type":17,"description":18,"interventionNames":19},"CCRT","ACTIVE_COMPARATOR","EBRT of 45-50.4Gy was delivered using IMRT technique to the pelvic ± para-aortic fields in 25-28 fractions, 5 days a week and was followed by brachytherapy of 24-30Gy in 3-5 fractions, once a week. Concurrent chemotherapy of cisplatin, with a dose of 40 mg\u002Fm2 by intravenous infusion, was administered once a week for 5 weeks during EBRT.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Toripalimab","Toripalimab combined with CCRT",[9],null,{"type":28,"name":16,"description":29,"armGroupLabels":30,"otherNames":26},"RADIATION","CCRT includes cisplatin (40 mg\u002Fm2, once a week for 5 weeks), radiotherapy (45-50.4Gy\u002F25-28Fx, 5 fractions a week, followed by brachytherapy 24-30Gy\u002F3-5Fx)",[16,9],[32],{"name":33,"affiliation":5,"role":34},"Haoping Xu","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Dan Ou","CONTACT","8618801970632","od12341@rjh.com.cn",[42],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Shanghai","Shanghai Municipality","200000","China","CN",{"type":50,"coordinates":51},"Point",[52,53],121.45806,31.22222,{"lat":53,"lon":52},[56],{"name":37,"role":38,"phone":57,"phoneExt":26,"email":40},"+8618801970632",{"type":34,"investigatorFullName":33,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Prof","100535776","toripalimab-combined-with-definitive-ccrt-for-lacc-patients-100535776",false,"NCT06256224","Toripalimab Combined With Definitive CCRT for LACC Patients","Toripalimab Combined With Definitive Chemoradiotherapy for Locally Advanced Cervical Squamous Cell Carcinoma Patients","Inclusion Criteria:\n\n* more than 18 years old females\n* had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix\n* FIGO 2018 stage IB3 to IVA with no evidence of distant metastasis\n* ECOG PS 0-1 without major organ failure\n* signed informed consent voluntarily\n\nExclusion Criteria:\n\n* previously suffered from immunodeficiency disorders\n* had any condition that researchers believed to be associated with increased risk of treatment\n* Previously received or currently receiving other PD-1 antibody treatments or other immunotherapies targeting PD-1\u002FPD-L1","FEMALE","18 Years",{"count":70,"type":71},150,"ESTIMATED","INTERVENTIONAL",[74],"NA","Cervical cancer constitutes a significant health burden for women globally. While most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent\u002Fmetastatic disease have a poor prognosis with standard treatments. Immunotherapies are a rational treatment for this HPV-driven cancer that commonly expresses programmed cell death ligand-1. Toripalimab, a humanized immunoglobulin G4 monoclonal antibody against PD-1, showed promising anti-tumor efficacy in multiple solid tumors. This randomised study is evaluating toripalimab combined with CCRT versus CCRT alone for treatment-naïve LACC.",[77,78,79],"Cervical Cancer","Chemoradiotherapy","Immunotherapy","2024-04-22",{"date":82,"type":83},"2024-04-24","ACTUAL",{"date":85,"type":83},"2024-02-02",{"date":87,"type":71},"2028-12-31",{"name":5,"class":6},1]