[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586495":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":45,"collaborators":20,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":70,"whyStopped":20,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"RenJi Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"treatment arm","EXPERIMENTAL","Neoadjuvant chemotherapy (TP regimen) combined with PD-1 inhibitor was given, followed by concurrent chemoradiotherapy (cisplatin and PD-1 inhibitor) , and PD-1 inhibitor maintenance was given sequenced after RT.",[13],"Drug: Neoadjuvant Chemotherapy (NACT)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Neoadjuvant Chemotherapy (NACT)","Neoadjuvant chemotherapy:\n\nThe neoadjuvant regimen prior to radiotherapy consists of paclitaxel 135-175 mg\u002Fm², cisplatin 75 mg\u002Fm², and Sintilimab 200 mg, administered every 3 weeks for 2 cycles.\n\nConcurrent chemoradiotherapy:\n\nRadical dose to the pelvic concurrent with cisplatin.\n\nConsolidative immunotherapy:\n\nFollowing the completion of chemoradiotherapy, Sintilimab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total of 6 cycles, starting 3-4 weeks after chemoradiotherapy.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Dr. Chen","CONTACT","86-21-68383624","chenhaiyan1220@163.com",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Renji Hospital","Shanghai","Shanghai Municipality","200127","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":25,"phoneExt":20,"email":44},"Chen Dr.","chenhaiyan@renji.com",{"type":46,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100586495","phase-2-neoadjuvant-chemo-immunotherapy-followed-by-concurrent-chemoradiotherapy-and-immunotherapy-in-lacc-100586495",false,"NCT06916117","Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in LACC","A Prospective Single Arm Trial of Neoadjuvant Chemo-immunotherapy Followed by Concurrent Chemoradiotherapy and Immunotherapy in Locally Advanced Cervical Cancer","Inclusion Criteria:\n\n* (1)Age between 18 and 75; (2)Untreated patients with pathologically proven squamous carcinoma; (3)T3-4N1-2M0 cervical cancer; (4)Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1; (5)Adequate hematological, renal and hepatic functions: (6)Hemoglobin \\> 8.0 g\u002Fdl ; Neutrophils \\> 2000 cells\u002Fμl; Leukocytes \\> 4 × 109\u002FL; Platelets \\> 100 × 109\u002FL; Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL); Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL); Serum ALT\u002FAST ≤ 2.5× UNL; Serum Total bilirubin ≤ 1.5× UNL; (7)Life expectancy \\> 6 months; (8)Eligible for concurrent chemoradiotherapy assessed by principle investigator; (9)No obvious active bleeding; (10)Written informed consent must be available before study registration.\n\nExclusion Criteria:\n\n* (1)Recurrent or distant metastatic disease; (2)Prior malignancies (other than curable non-melanoma skin cancer) within 5 years; (3)Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants; (4)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; (5)Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study; (6)Previous organ transplantation or HIV patients; (7)Allergic to macromolecular proteins \u002Fmonoclonal antibodies, or to any test drug component; (8)Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\\> 2000 IU\u002Fml or 104 copies\u002Fml; hepatitis C virus (HCV) RNA\\> 10\\^3 copies\u002Fml.","FEMALE","18 Years","75 Years",{"count":58,"type":59},30,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","Concurrent chemoradiotherapy -immunotherapy followed by ICI maintenance was proved to improve the PFS by the Keynote-A18 in the LACC patients, and still more than 30% progressed. Neoadjuvant chemo-immunotherapy in LACC resulted in higher pCR rate. This prospective single arm study is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy in LACC patients.",[65],"Locally Advanced Cervical Cancer",[67,68,69],"immunotherapy","LACC","chemoradiotherapy","NOT_YET_RECRUITING","2025-03-31",{"date":73,"type":74},"2025-04-08","ACTUAL",{"date":76,"type":59},"2025-04-05",{"date":78,"type":59},"2028-12-30",{"name":5,"class":6},1]