protocolSection identificationModule nctId: NCT06289062, orgStudyIdInfo id: NACI-CERV-005, briefTitle: Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2030-12-01, studyFirstPostDateStruct date: 2024-03-01, lastUpdatePostDateStruct date: 2024-03-01, sponsorCollaboratorsModule leadSponsor name: Tongji Hospital, class: OTHER, collaborators name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, collaborators name: Women Hospital, School of Medicine, Zhejiang University, collaborators name: Third Military Medical University, collaborators name: Beijing Friendship Hospital, collaborators name: Sichuan Cancer Hospital and Research Institute, collaborators name: Tianjin Medical University, collaborators name: West China Second University Hospital, collaborators name: Xiangya Hospital of Central South University, collaborators name: Qilu Hospital of Shandong University, collaborators name: Gansu Cancer Hospital, collaborators name: Zhejiang Cancer Hospital, collaborators name: Shengjing Hospital, collaborators name: Anhui Provincial Cancer Hospital, descriptionModule briefSummary: This multicenter, prospective clinical trial is designed to enroll PD-L1 expression-positive patients with stage IB1 cervical cancer who desire fertility preservation to undergo neoadjuvant chemotherapy in combination with a PD-1 inhibitor to evaluate the rate of complete pathologic remission, treatment-related adverse events, pregnancy rate, miscarriage rate, preterm birth rate, live birth rate, PFS and OS., conditionsModule conditions: Cervical Cancer, conditions: Neoadjuvant Chemoimmunotherapy, conditions: Fertility Preservation, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Camrelizumab, interventions name: Cisplatin, interventions name: Nab paclitaxel, interventions name: biopsy, outcomesModule primaryOutcomes measure: Pathologic complete response, secondaryOutcomes measure: The negative conversion of HPV, secondaryOutcomes measure: Pregnancy rate, secondaryOutcomes measure: Miscarriage rate, secondaryOutcomes measure: Live birth rate, secondaryOutcomes measure: Preterm birth rate, secondaryOutcomes measure: Adverse Event, secondaryOutcomes measure: Surgical complications, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Physical Function Score, secondaryOutcomes measure: Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Symptom Specific Scale for Cervical Cancer (EORTC QLQ-CX24) Score, secondaryOutcomes measure: Event-free survival (EFS), secondaryOutcomes measure: Overall survival (OS), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 45 Years, stdAges: 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: Kezhen Li, role: CONTACT, phone: 086-027-8362, email: tjkeke@126.com, contacts name: Jing Chen, role: CONTACT, phone: 086-027-8362, email: chenjing3223@126.com, contacts name: Kezhen Li, role: PRINCIPAL_INVESTIGATOR, contacts name: Gang Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, hasResults: False