[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546150":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":22,"locations":23,"responsibleParty":42,"collaborators":22,"id":44,"slug":22,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":22,"eligibilityCriteria":49,"healthyVolunteers":45,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":22,"studyType":56,"phases":57,"briefSummary":60,"conditions":61,"keywords":22,"overallStatus":26,"whyStopped":22,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment arm","EXPERIMENTAL","with Albumin-Bound Paclitaxel 50-75mg\u002Fm2, cisplatin 25-40 mg\u002Fm2 weekly for up to 5 cycles during radical radiation (EBRT followed by brachytherapy); followed by Sintilimab 200mg Q3W for 8 cycles.",[13],"Drug: Albumin-Bound Paclitaxel, cisplatin, Sintilimab",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Albumin-Bound Paclitaxel, cisplatin, Sintilimab","with Albumin-Bound Paclitaxel 50-75mg\u002Fm2, cisplatin 25-40 mg\u002Fm2 weekly for up to 5 cycles during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles",[9],[21],"radiation",null,[24],{"facility":25,"status":26,"city":27,"state":22,"zip":28,"country":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"RenJi hospital","RECRUITING","Shanghai","200127","China",{"type":31,"coordinates":32},"Point",[33,34],121.45806,31.22222,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},"Yongrui Bai, Dr","CONTACT","+862168383459","baiyongrui@renji.com",{"type":43,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100546150",false,"NCT06391190","Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer","A Prospective Single Arm Trial of Concurrent Chemoradiotherapy (With Albumin-Bound Paclitaxel\u002FCisplatin) Followed by PD-1 Inhibitor in Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n1. Age between 18 and 75;\n2. Untreated patients with pathologically proven locally advanced cervical cancer;\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1\n4. Adequate hematological, renal and hepatic functions:\n\n   4.1 Hemoglobin \\> 8.0 g\u002Fdl 4.2 Neutrophils \\> 2000 cells\u002Fμl; Leukocytes \\> 4 × 109\u002FL 4.3 Platelets \\> 100 × 109\u002FLg. 4.4 Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) 4.5 Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) 4.6 Serum ALT\u002FAST ≤ 2.5× UNL 4.7 Serum Total bilirubin ≤ 1.5× UNL\n5. Life expectancy \\> 6 months\n6. Eligible for concurrent chemoradiotherapy assessed by principle investigator;\n7. No obvious active bleeding;\n8. Written informed consent must be available before study registration.\n\nExclusion Criteria:\n\n1. Recurrent or distant metastatic disease;\n2. Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;\n3. Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;\n4. Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;\n5. Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;\n6. Previous organ transplantation or HIV patients;\n7. Allergic to macromolecular proteins \u002Fmonoclonal antibodies, or to any test drug component;\n8. Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\\> 2000IU\u002Fml or 104 copies\u002Fml; hepatitis C virus (HCV) RNA\\> 103 copies\u002Fml.","FEMALE","18 Years","75 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58,59],"PHASE1","PHASE2","To explore the safety and efficacy of Albumin-Bound Paclitaxel\u002FPlatinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer",[62,63,64],"Locally Advanced Cervical Carcinoma","Concurrent Chemoradiotherapy","Immunotherapy","2024-04-25",{"date":67,"type":68},"2024-04-30","ACTUAL",{"date":70,"type":68},"2022-01-01",{"date":72,"type":55},"2026-12-30",{"name":5,"class":6},1]