[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641687":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":25,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":55,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":25,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Patients received three cycles of neoadjuvant cadonilimab plus chemotherapy. Patients subsequently underwent radical hysterectomy with pelvic lymphadenectomy, with para-aortic lymph node biopsy\u002Fdissection performed when indicated. Postoperative adjuvant therapy was administered according to pathological findings.",[13],"Procedure: Neoadjuvant Therapy Plus Surgery",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","ACTIVE_COMPARATOR","Patients received standard concurrent chemoradiotherapy (CCRT), consisting of external beam radiotherapy combined with concurrent platinum-based chemotherapy.",[19],"Procedure: Concurrent Chemoradiotherapy",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Neoadjuvant Therapy Plus Surgery",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Concurrent Chemoradiotherapy",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Xin Wu","CONTACT","86 21 33189900","wuxin_fc@fudan.edu.cn",[36],{"facility":37,"status":25,"city":38,"state":25,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Obstetrics and Gynecology Hospital of Fudan University","Shanghai","201101","China","CN",{"type":43,"coordinates":44},"Point",[45,46],121.45806,31.22222,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":33,"phoneExt":25,"email":34},"Xin Wu, Dr",{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100641687","phase-2-cadonilimab-plus-chemotherapy-in-lacc-a-prospective-multicenter-randomized-phase-ii-trial-100641687",false,"NCT07649174","Cadonilimab Plus Chemotherapy in LACC: A Prospective, Multicenter, Randomized Phase II Trial","Efficacy of Cadonilimab in Combination With Chemotherapy as Neoadjuvant Treatment for Locally Advanced Cervical Cancer: A Prospective, Multicenter, Randomized Phase II Trial","Inclusion Criteria:\n\n1. Patients with previously untreated locally advanced cervical cancer, clinically staged as FIGO 2018 stage IB3, IIA2, IIB, or IIIC1r (tumor diameter \\>4 cm as assessed by contrast-enhanced pelvic MRI);\n2. Histologically or cytologically confirmed cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma;\n3. Female patients aged ≥18 and ≤75 years;\n4. Willing and able to provide written informed consent and comply with study visits and protocol-required procedures;\n5. Eligible for radical hysterectomy with curative intent;\n6. At least one measurable lesion according to RECIST version 1.1;\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n8. Estimated life expectancy of at least 6 months;\n9. Women of childbearing potential must agree to use effective contraception throughout the study period. A negative serum or urine pregnancy test is required before study enrollment.\n\nExclusion Criteria:\n\n1. Histological subtypes other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma, including but not limited to small cell carcinoma and clear cell carcinoma.\n2. Clinically significant unrecoverable hydronephrosis;\n3. CNS metastases or leptomeningeal disease;\n4. Active malignancy within 3 years prior to enrollment (with specified exceptions);\n5. Prior exposure to immune checkpoint inhibitors or other immunomodulatory anticancer therapies;\n6. Major surgery within 4 weeks before study treatment;\n7. Severe cardiovascular or cerebrovascular disease;\n8. Unresolved toxicities from previous anticancer therapy (\\> Grade 1, CTCAE v5.0);\n9. Known hypersensitivity to study drugs;\n10. Serious medical or psychiatric conditions that may interfere with study participation;\n11. Pregnancy.","FEMALE","18 Years","75 Years",{"count":64,"type":65},134,"ESTIMATED","INTERVENTIONAL",[68],"PHASE2","This is a prospective, multi-center, randomized controlled phase II clinical trial aimed at exploring the efficacy evaluation of cadilonilumab immunotherapy combined with chemotherapy for locally advanced cervical cancer.",[71],"Cervical Cancer",[73,74,75],"cervical cancer","Immunotherapy","Neoadjuvant therapy","NOT_YET_RECRUITING","2026-06-11",{"date":79,"type":80},"2026-06-16","ACTUAL",{"date":82,"type":65},"2026-06-06",{"date":84,"type":65},"2030-12-31",{"name":5,"class":6},1]