[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478565":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":32,"studyPopulation":24,"armGroups":33,"interventions":46,"overallOfficials":58,"centralContacts":62,"locations":71,"responsibleParty":85,"collaborators":24,"id":87,"slug":24,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":24,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":24,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":73,"whyStopped":24,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":24},[9,13],{"measure":10,"description":11,"timeFrame":12},"3-year progress free survival rate","Progression-free survival (PFS) is defined as the time between entry into the study and progression of the tumor (in any respect) or death (from any cause).","up to 3 years",{"measure":14,"description":15,"timeFrame":12},"side effect rate","Number of participants with treatment-related adverse events as assessed by CTCAE v5.0",[17,21],{"measure":18,"description":19,"timeFrame":20},"Objective response rate(ORR)","ORR is defined as the proportion of patients with CR or PR, assessed by RECIST v1.1 per independent central radiologic review.","3 months, after chemoradiotherapy",{"measure":22,"description":23,"timeFrame":12},"3-year overall survival rate","overall survival rate（OS）is calculated from the date of entry into the study to the date of death or the last follow-up visit.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"RANDOMIZED","PARALLEL","Patients will be randomized (1:1) to Arm A or Arm B.","TREATMENT",{"masking":31,"maskingDescription":24,"whoMasked":24},"NONE","This is a multicenter, prospective, and randomized phase II clinical trial. Patients assigned to experimental group will receive standard radiotherapy with concomitant cisplatin 40mg\u002Fm2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year. Patients assigned to control group will undergo standard radiotherapy with concomitant cisplatin 40mg\u002Fm2 once every week for 5 weeks. Compare the efficacy and toxicity of the two regimens in patients with stage IIIC2 cervical cancer.",[34,40],{"label":35,"type":36,"description":37,"interventionNames":38},"tislelizumab","EXPERIMENTAL","The external radiation is administered at 45-50Gy\u002F25f and brachytherapy is performed sequentially at 6Gy\u002Ftime to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg\u002Fm2 on day 1 once every week for 5 weeks. In addition, patients also receive tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.",[39],"Drug: tislelizumab",{"label":41,"type":42,"description":43,"interventionNames":44},"concurrent chemoradiotherapy","ACTIVE_COMPARATOR","The external radiation is administered at 45-50Gy\u002F25f and brachytherapy is performed sequentially at 6Gy\u002Ftime to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg\u002Fm2 on day 1 once every week for 5 weeks.",[45],"Other: concurrent chemoradiotherapy",[47,53],{"type":48,"name":35,"description":49,"armGroupLabels":50,"otherNames":51},"DRUG","standard radiotherapy with concomitant cisplatin 40mg\u002Fm2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.",[35],[52],"pd-1 antibody",{"type":6,"name":41,"description":54,"armGroupLabels":55,"otherNames":56},"standard radiotherapy with concomitant cisplatin 40mg\u002Fm2 on day 1 once every week for 5 weeks.",[41],[57],"DDP combined with radiotherapy",[59],{"name":60,"affiliation":5,"role":61},"fang wu, M.D.","PRINCIPAL_INVESTIGATOR",[63,68],{"name":64,"role":65,"phone":66,"phoneExt":24,"email":67},"shanshan ma, M.D.","CONTACT","07715356509","56716690@qq.com",{"name":69,"role":65,"phone":66,"phoneExt":24,"email":70},"yong zhang, M.D.","zhangyonggx@163.com",[72],{"facility":5,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":24},"RECRUITING","Nanning","Guangxi","530021","China","CN",{"type":80,"coordinates":81},"Point",[82,83],108.31667,22.81667,{"lat":83,"lon":82},{"type":86,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100478565",false,"NCT05511623","Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer","Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer","Inclusion criteria:\n\n(1)18-70 years old; (2)Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)Patients with 2018 FIGO stage IIIC2 cervical cancer; (4)At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; (5)Eastern Cooperative Oncology Group score 0-1; (6)No metastatic diseases; (7)Must have an average life expectancy of 6 months; (8)Participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g\u002FL,neutrophils ≥1.5×109\u002FL, platelets ≥80×109\u002FL, ALB≥30g\u002FL, Total bilirubin≤1.5 x institutional upper limit of normal, AST(SGOT)\u002FALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance≥60 mL\u002Fmin; (9)Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)Patients volunteered to participate in the study and sign the informed consent.\n\nExclusion criteria:\n\n1. Diagnosed with any other cancer within the past 5 years;\n2. Known allergy to any component of the drug;\n3. Congenital or acquired immune deficiency (such as HIV infection);\n4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention;\n5. Active infection requiring systemic treatment;\n6. Previously treatment with PD-1 and\u002For PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors;\n7. Patients with grade\\>2 unrelieved toxic reactions (based on National Cancer Institute Common Terminology Criteria for Adverse Events \\[NCI CTCAE\\] version 5.0) caused by any previous treatment;\n8. With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis;\n9. Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;\n10. Pregnant or lactating women;\n11. With metastatic diseases;\n12. Liver\u002Frenal insufficiency;\n13. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders;\n14. Those who have participated in clinical trials with other drugs within 4 weeks;\n15. Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator;\n16. Patients could not gain the maximum benefit from this study judged by the investigator.","FEMALE","18 Years","70 Years",{"count":97,"type":98},112,"ESTIMATED","INTERVENTIONAL",[101],"PHASE2","To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.",[104],"Cervical Cancer",[106,107,108],"cervical carcinoma","PD-1","chemoradiotherapy","2023-09-08",{"date":111,"type":112},"2023-09-11","ACTUAL",{"date":114,"type":112},"2022-09-01",{"date":116,"type":98},"2027-12-31",{"name":5,"class":6},1]