[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478565":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":46,"responsibleParty":60,"collaborators":41,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":41,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":41,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":48,"whyStopped":41,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"First Affiliated Hospital of Guangxi Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Drug: tislelizumab",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Other: concurrent chemoradiotherapy",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],[26],"pd-1 antibody",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"standard radiotherapy with concomitant cisplatin 40mg\u002Fm2 on day 1 once every week for 5 weeks.",[15],[31],"DDP combined with radiotherapy",[33],{"name":34,"affiliation":5,"role":35},"fang wu, M.D.","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"shanshan ma, M.D.","CONTACT","07715356509",null,"56716690@qq.com",{"name":44,"role":39,"phone":40,"phoneExt":41,"email":45},"yong zhang, M.D.","zhangyonggx@163.com",[47],{"facility":5,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":41},"RECRUITING","Nanning","Guangxi","530021","China","CN",{"type":55,"coordinates":56},"Point",[57,58],108.31667,22.81667,{"lat":58,"lon":57},{"type":61,"investigatorFullName":41,"investigatorTitle":41,"investigatorAffiliation":41,"oldNameTitle":41,"oldOrganization":41},"SPONSOR","100478565","phase-2-tislelizumab-combined-with-concurrent-chemoradiotherapy-as-first-line-treatment-for-stage-iiic2-cervical-cancer-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":73,"type":74},112,"ESTIMATED","INTERVENTIONAL",[77],"PHASE2","To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.",[80],"Cervical Cancer",[82,83,84],"cervical carcinoma","PD-1","chemoradiotherapy","2023-09-08",{"date":87,"type":88},"2023-09-11","ACTUAL",{"date":90,"type":88},"2022-09-01",{"date":92,"type":74},"2027-12-31",{"name":5,"class":6},1]