[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546150":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":22,"locations":23,"responsibleParty":43,"collaborators":22,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":22,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":22,"studyType":58,"phases":59,"briefSummary":62,"conditions":63,"keywords":22,"overallStatus":26,"whyStopped":22,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"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,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"RenJi hospital","RECRUITING","Shanghai","200127","China","CN",{"type":32,"coordinates":33},"Point",[34,35],121.45806,31.22222,{"lat":35,"lon":34},[38],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Yongrui Bai, Dr","CONTACT","+862168383459","baiyongrui@renji.com",{"type":44,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100546150","phase-1-concurrent-chemoradiotherapy-followed-by-pd-1-inhibitor-in-advanced-cervical-cancer-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":56,"type":57},20,"ESTIMATED","INTERVENTIONAL",[60,61],"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",[64,65,66],"Locally Advanced Cervical Carcinoma","Concurrent Chemoradiotherapy","Immunotherapy","2024-04-25",{"date":69,"type":70},"2024-04-30","ACTUAL",{"date":72,"type":70},"2022-01-01",{"date":74,"type":57},"2026-12-30",{"name":5,"class":6},1]