[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538302":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":37,"centralContacts":41,"locations":50,"responsibleParty":87,"collaborators":89,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":23,"eligibilityCriteria":122,"healthyVolunteers":118,"sex":123,"minAge":124,"maxAge":125,"enrollmentInfo":126,"targetDuration":23,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":23,"overallStatus":53,"whyStopped":23,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NACI in FIGO ⅠB1 Cervical Cancer","EXPERIMENTAL","Neoadjuvant chemotherapy plus camrelizumab for ⅠB1 Cervical Cancer. Patients first received one cycle of platinum-based doublet priming chemotherapy. After 3 weeks, participants subsequently received two cycles of the PD-1 inhibitor camrelizumab combined with chemotherapy every 3 weeks. The study will be conducted in two stages: (1) Patients enrolled in the first stage with tumors ≤2 cm and no new lesions after completion of treatment will undergo cone biopsy + pelvic lymphadenectomy or SLN mapping. Those who meet ConCerv criteria will undergo a second TCT, human papillomavirus (HPV) and colposcope 3 months later, and those who do not meet ConCerV criteria will undergo radical cervical surgery. (2) Patients enrolled in the second stage with tumors ≤2 cm and no new lesions underwent cervical biopsy + pelvic lymphadenectomy or SLN mapping; patients with LSIL on biopsy underwent TCT, HPV, and colposcope 3 months later; if biopsy suggests HSIL and above, perform cone biopsy.",[13,14,15,16],"Drug: Camrelizumab","Drug: Cisplatin","Drug: Nab paclitaxel","Procedure: biopsy",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Camrelizumab","Camrelizumab is administered at 200mg, q3w (second and third cycles) before radical surgery",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Cisplatin","75-80mg\u002Fm2, D1-D2，q3w (3 cycles)，intravenous infusion, administered at a rate of 1mg\u002Fmin.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Nab paclitaxel","260 mg\u002Fm2，D1，q3w （3 cycles），intravenous infusion, administered over 30min.",[9],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":23},"PROCEDURE","biopsy","cone biopsy + pelvic lymphadenectomy or Cervical biopsy + pelvic lymphadenectomy",[9],[38],{"name":39,"affiliation":5,"role":40},"Ding Ma","STUDY_CHAIR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},"Kezhen Li","CONTACT","086-027-8362","tjkeke@126.com",{"name":48,"role":44,"phone":45,"phoneExt":23,"email":49},"Jing Chen","chenjing3223@126.com",[51,71],{"facility":52,"status":53,"city":54,"state":55,"zip":23,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University","RECRUITING","Guangzhou","Guangdong","China","CN",{"type":59,"coordinates":60},"Point",[61,62],113.25,23.11667,{"lat":62,"lon":61},[65,68],{"name":66,"role":44,"phone":23,"phoneExt":23,"email":67},"Huaiwu, PhD","luhuaiwu@163.com",{"name":69,"role":70,"phone":23,"phoneExt":23,"email":23},"Huaiwu Lu, PhD","PRINCIPAL_INVESTIGATOR",{"facility":72,"status":53,"city":73,"state":74,"zip":75,"country":56,"countryCode":57,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan","Hubei","430030",{"type":59,"coordinates":77},[78,79],114.26667,30.58333,{"lat":79,"lon":78},[82,83,84,85],{"name":43,"role":44,"phone":45,"phoneExt":23,"email":46},{"name":48,"role":44,"phone":45,"phoneExt":23,"email":49},{"name":43,"role":70,"phone":23,"phoneExt":23,"email":23},{"name":86,"role":70,"phone":23,"phoneExt":23,"email":23},"Gang Chen",{"type":70,"investigatorFullName":43,"investigatorTitle":88,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Prof",[90,92,94,96,98,100,102,104,106,108,110,112,114],{"name":91,"class":6},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"name":93,"class":6},"Women's Hospital School Of Medicine Zhejiang University",{"name":95,"class":6},"Third Military Medical University",{"name":97,"class":6},"Beijing Friendship Hospital",{"name":99,"class":6},"Sichuan Cancer Hospital and Research Institute",{"name":101,"class":6},"Tianjin Medical University",{"name":103,"class":6},"West China Second University Hospital",{"name":105,"class":6},"Xiangya Hospital of Central South University",{"name":107,"class":6},"Qilu Hospital of Shandong University",{"name":109,"class":6},"Gansu Cancer Hospital",{"name":111,"class":6},"Zhejiang Cancer Hospital",{"name":113,"class":6},"Shengjing Hospital",{"name":115,"class":6},"Anhui Provincial Cancer Hospital","100538302","phase-2-neoadjuvant-chemotherapy-plus-camrelizumab-for-figo-stage-ib1-cervical-cancer-100538302",false,"NCT06289062","Neoadjuvant Chemotherapy Plus Camrelizumab for FIGO Stage IB1 Cervical Cancer","Neoadjuvant Chemotherapy Plus Camrelizumab (NACI Therapy) for Fertility Preservation in FIGO Stage IB1 Cervical Cancer","Inclusion Criteria:\n\n1. Clinical diagnosis of stage IB1 cervical cancer after gynecologic examination and MRI evaluation by the investigator (FIGO 2018);\n2. Pathologically confirmed diagnosis of cervical squamous cell carcinoma;\n3. Transformation zone of TZ1 or TZ2 (IFCPC 2011);\n4. Positive PD-L1 expression by preoperative pathology, i.e., Combined Positive Score (CPS) ≥1;\n5. Patient age ≥18 years and ≤45 years;\n6. ECOG score ≤1;\n7. Laboratory tests: white blood cell (WBC) ≥3. 5×109\u002FL, Neutrophil (NEU) ≥1. 5×109\u002FL, platelet (PLT) ≥100×109\u002FL, serum bilirubin ≤1.5 times the upper limit of normal, aminotransferase ≤1.5 times the upper limit of normal, and blood urea nitrogen （BUN) and Cr ≤normal;\n8. Have a strong desire to give birth;\n9. Willing to sign the informed consent form, including compliance with the requirements and restrictions listed in the informed consent form and program.\n\nExclusion Criteria:\n\n1. History of infertility, including those with infertility due to tubal or (and) husband;\n2. Any active autoimmune disease or history of autoimmune disease requiring systemic treatment, including, but not limited to, autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, asthma requiring bronchodilator intervention;\n3. Prior treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known hypersensitivity to any component of the study medication or other monoclonal antibodies;\n4. History of human immunodeficiency virus (HIV) infection or known active hepatitis B or C;\n5. Use of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppression (\\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to study dosing;\n6. History of primary malignancy or receipt of chemotherapy or pelvic radiation;\n7. Concurrent participation in other clinical trials;\n8. Pregnant or breastfeeding female patients; subjects must agree to use effective contraception during study treatment, within 5 months of last use of immune check inhibitors, within 6 months of last use of chemotherapeutic agents, and if there is no confirmation that the lesion has been removed or that the pathology is in remission;\n9. Uncontrolled co-morbidities, including but not limited to New York Heart Association (NYHA) class 2 or higher, severe\u002Funstable angina pectoris, myocardial infarction within ≤ 6 months prior to study drug administration, severe arrhythmias requiring medication or intervention; difficult-to-control hypertension; and cerebral vascular accidents or brain disorders within ≤ 6 months prior to study drug administration, or those with adjudicated abnormal behavioral skills; hematologic disorders: coagulation abnormalities (INR \\> 2. 0, Prothrombin time (PT) \\> 16s), bleeding tendency, or undergoing thrombolytic or anticoagulant therapy; abnormalities in hepatic or renal development or a history of surgery; and any active infection requiring systemic anti-infective therapy within 14 days prior to the first dose of study drug;\n10. Treatment with live or attenuated vaccine within 4 weeks prior to the first dose of study drug; inactivated seasonal influenza virus vaccine is permitted;\n11. Patients who have received a previous allogeneic bone marrow or solid organ transplant;\n12. Drug and\u002For alcohol abuse;\n13. Patients who, in the opinion of the investigator, are unlikely to comply with the study procedures, restrictions, and requirements may not participate in this study.","FEMALE","18 Years","45 Years",{"count":127,"type":128},40,"ESTIMATED","INTERVENTIONAL",[131],"PHASE2","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, EFS and OS.",[134,135,136],"Cervical Cancer","Neoadjuvant Chemoimmunotherapy","Fertility Preservation","2024-11-01",{"date":139,"type":140},"2024-11-05","ACTUAL",{"date":142,"type":140},"2024-05-08",{"date":144,"type":128},"2030-12-01",{"name":5,"class":6},2]