protocolSection identificationModule nctId: NCT06289751, orgStudyIdInfo id: NACI-CerV-004, briefTitle: Neoadjuvant Chemoimmunotherapy and Extrafascial Hysterectomy for IB2 Cervical Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2026-03-01, completionDateStruct date: 2031-01-01, studyFirstPostDateStruct date: 2024-03-04, lastUpdatePostDateStruct date: 2024-03-04, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), collaborators name: Women Hospital, School of Medicine, Zhejiang University, collaborators name: Southwest Hospital, China, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: Qilu Hospital of Shandong University, collaborators name: Beijing Friendship Hospital, collaborators name: Tianjin Medical University, collaborators name: West China Second University Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: Gansu Provincial Maternal and Child Health Care Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Shengjing Hospital, descriptionModule briefSummary: This study is an exploratory clinical trial to investigate the feasibility of neoadjuvant chemoimmunotherapy plus extrafascial hysterectomy and pelvic lymph node dissection in patients with stage IB2 (2018 FIGO) cervical cancer and to observe the response rate to treatment, adverse effects and complications, and to assess the survival rate of patients., conditionsModule conditions: Cervical Cancer, conditions: Neoadjuvant Chemoimmunotherapy, conditions: Radical Hysterectomy, conditions: Fertility Preservation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: a multicentre, single-arm, phase 2 trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Cadonilimab, interventions name: Paclitaxel-albumin, interventions name: Cisplatin, interventions name: Extrafascial hysterectomy, outcomesModule primaryOutcomes measure: Percentage of patients meeting ConCerV criteria, secondaryOutcomes measure: Objective Response Rate, ORR, secondaryOutcomes measure: Proportion of patients requiring postoperative adjuvant therapy, secondaryOutcomes measure: Number of Participants with Treatment-Emergent Adverse Events as assessed by CTCAE v4.0, secondaryOutcomes measure: the surgical complication, secondaryOutcomes measure: Pathologic Complete Response, secondaryOutcomes measure: Overall survival, OS, secondaryOutcomes measure: progression-free survival, PFS, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, city: Wuhan, state: Hubei, zip: 430030, country: China, contacts name: Gang Chen, role: CONTACT, phone: 086-027-8362, email: gumpc@126.com, contacts name: Jing Chen, role: CONTACT, phone: 086-027-8362, email: chenjing3223@126.com, contacts name: Gang Chen, role: PRINCIPAL_INVESTIGATOR, contacts name: Kezhen Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False