[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605874":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":11,"studyPopulation":11,"armGroups":50,"interventions":64,"overallOfficials":11,"centralContacts":86,"locations":95,"responsibleParty":117,"collaborators":11,"id":119,"slug":11,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":11,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":11,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":11,"overallStatus":98,"whyStopped":11,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Shanghai Shengdi Pharmaceutical Co., Ltd","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-free survival (PFS)",null,"Up to approximately 36 months.",[14,18,21,25,27,29,31,33,35,37],{"measure":15,"description":16,"timeFrame":17},"Overall survival (OS)","OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.","Up to approximately 60 months.",{"measure":19,"description":20,"timeFrame":17},"3-year overall survival (OS) rate","OS rate within 3 years.",{"measure":22,"description":23,"timeFrame":24},"2-year progression-free survival (PFS)","PFS within 2 years.","Up to approximately 24 months.",{"measure":26,"description":11,"timeFrame":12},"Objective Response Rate (ORR)",{"measure":28,"description":11,"timeFrame":17},"Duration of response (DoR)",{"measure":30,"description":11,"timeFrame":12},"Local recurrence rate",{"measure":32,"description":11,"timeFrame":17},"Distant metastasis rate",{"measure":34,"description":11,"timeFrame":17},"The second disease progression assessed by the investigator",{"measure":36,"description":11,"timeFrame":17},"Adverse events (AEs) including incidence and grade correlation with study drugs",{"measure":38,"description":11,"timeFrame":17},"Rate of suspension and discontinuation due to an adverse event correlation with study drugs",{"allocation":40,"interventionModel":41,"interventionModelDescription":11,"primaryPurpose":42,"observationalModel":11,"timePerspective":11,"maskingInfo":43},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":44,"maskingDescription":11,"whoMasked":45},"QUADRUPLE",[46,47,48,49],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[51,59],{"label":52,"type":53,"description":11,"interventionNames":54},"SHR-1316 Group","EXPERIMENTAL",[55,56,57,58],"Drug: SHR-1316 Injection","Drug: Cisplatin Injection","Drug: Carboplatin Injection","Drug: Paclitaxel Injection",{"label":60,"type":61,"description":11,"interventionNames":62},"SHR-1316 Placebo Group","PLACEBO_COMPARATOR",[56,57,58,63],"Drug: SHR-1316 Placebo Injection",[65,70,74,78,82],{"type":66,"name":67,"description":68,"armGroupLabels":69,"otherNames":11},"DRUG","SHR-1316 Injection","SHR-1316 injection.",[52],{"type":66,"name":71,"description":72,"armGroupLabels":73,"otherNames":11},"Cisplatin Injection","Cisplatin injection.",[52,60],{"type":66,"name":75,"description":76,"armGroupLabels":77,"otherNames":11},"Carboplatin Injection","Carboplatin injection.",[52,60],{"type":66,"name":79,"description":80,"armGroupLabels":81,"otherNames":11},"Paclitaxel Injection","Paclitaxel injection.",[52,60],{"type":66,"name":83,"description":84,"armGroupLabels":85,"otherNames":11},"SHR-1316 Placebo Injection","SHR-1316 placebo injection.",[60],[87,92],{"name":88,"role":89,"phone":90,"phoneExt":11,"email":91},"Xiaoxu Zhang","CONTACT","+86-0518-82342973","xiaoxu.zhang@hengrui.com",{"name":93,"role":89,"phone":90,"phoneExt":11,"email":94},"Zhaoyu Zhong","zhaoyu.zhong.zz8@hengrui.com",[96],{"facility":97,"status":98,"city":99,"state":100,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":110},"Fudan University Shanghai Cancer Center","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":105,"coordinates":106},"Point",[107,108],121.45806,31.22222,{"lat":108,"lon":107},[111,115],{"name":112,"role":89,"phone":113,"phoneExt":11,"email":114},"Xiaohua Wu","+86-021-64175590","wu.xh@fudan.edu.cn",{"name":112,"role":116,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"type":118,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100605874",false,"NCT07168200","A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer","A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Participate in the study voluntarily, sign the informed consent form.\n2. Subjects were able to provide primary or metastatic cancer samples.\n3. At least one measurable lesion.\n4. Expected survival \\> 3 months.\n5. ECOG 0 \\~ 1.\n6. With adequate organ functions.\n\nExclusion Criteria:\n\n1. Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.\n2. Administering live vaccines within 4 weeks before enrollment or during planned study treatment.\n3. Participants who received immunosuppressive therapy within 4 weeks before enrolment.\n4. For participants who are receiving thrombolytic\u002Fanticoagulant therapy, prophylactic anticoagulant therapy is allowed.\n5. Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.\n6. Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.\n7. Pregnant or breastfeeding women.\n8. According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.","FEMALE","18 Years","75 Years",{"count":129,"type":130},720,"ESTIMATED","INTERVENTIONAL",[133],"PHASE3","This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).",[136],"Advanced Cervical Cancer","2026-04-12",{"date":139,"type":140},"2026-04-15","ACTUAL",{"date":142,"type":140},"2025-10-17",{"date":144,"type":130},"2028-12",{"name":5,"class":6},1]