[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525955":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":42,"overallOfficials":57,"centralContacts":62,"locations":25,"responsibleParty":68,"collaborators":25,"id":71,"slug":25,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":25,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":25,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":25,"overallStatus":89,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":25},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"changes in tumor-related biomarkers","changes of tumor- related biomarkers (T cell receptor library profile and peripheral blood ctDNA content analysis)","3 years",[14,18,22],{"measure":15,"description":16,"timeFrame":17},"OS","Overall Survival","5 years",{"measure":19,"description":20,"timeFrame":21},"DFS","Disease Free Survival","2 years",{"measure":23,"description":24,"timeFrame":12},"AE","Adverse event",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"NA","SINGLE_GROUP","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","For cervical cancer, although clinical research on PD-1 monoclonal antibodies was launched relatively late, the research results so far show that PD-1 monoclonal antibodies combined with chemotherapy have a high clinical effectiveness and a relatively high efficacy in the treatment of advanced\u002Frecurrent cervical cancer. Good security. However, there is currently a lack of clinical evidence for the use of PD-1 monoclonal antibodies combined with chemoradiotherapy in the treatment of high-risk patients after cervical cancer surgery. Therefore, this study intends to explore the clinical efficacy of postoperative adjuvant radiochemotherapy followed by PD-1 monoclonal antibody in the treatment of high-risk patients with locally advanced (IB3, IIA2) cervical cancer after surgery, and provide a new solution for clinical treatment.",[34],{"label":35,"type":36,"description":37,"interventionNames":38},"Concurrent themoradiotherapy Followed by Zimberelimab","EXPERIMENTAL","1. Radiotherapy: Intensity modulated conformal radiation therapy (IMRT) is used for external irradiation, and the pelvic target volume dose (PTV) is: 45-50 Gy\u002F1.8Gy\u002F25-28f; the stump margin is positive, and after the external irradiation is completed, Additional CT-guided three-dimensional conformal brachytherapy, HR-CTV: 24--30Gy\u002F4-5f.\n2. Concurrent chemotherapy: performed during external radiotherapy. Starting from the first week of radiochemotherapy, cisplatin 40 mg\u002Fm2 was given. Chemotherapy is given every 7 days, up to 5-6 times;\n3. Zimberelimab injection: 240 mg\u002Ftime, intravenous infusion, administered every 21 days, starting within four weeks after completing concurrent chemoradiotherapy, and maintained for 8 cycles",[39,40,41],"Drug: Zimberelimab","Drug: Platinum","Radiation: radiotherapy",[43,48,52],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":25},"DRUG","Zimberelimab","240mg, q3w，8 cycles",[35],{"type":44,"name":49,"description":50,"armGroupLabels":51,"otherNames":25},"Platinum","cisplatin 40mg\u002Fm2 for 5-6 cycles",[35],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":25},"RADIATION","radiotherapy","45-50Gy\u002F1.8Gy\u002F25-28f",[35],[58],{"name":59,"affiliation":60,"role":61},"Keqin Hua, Doctor","Gynecology and obstetrics hospital of fudan university","PRINCIPAL_INVESTIGATOR",[63],{"name":64,"role":65,"phone":66,"phoneExt":25,"email":67},"Junjun Qiu, Doctor","CONTACT","18017738139","qiujunjun1113@163.com",{"type":61,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Keqin Hua","Director of Gynecological Oncology","100525955",false,"NCT06128460","Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer.","Adjuvant Chemoradiotherapy Followed by Zimberelimab for Locally Advanced Cervical Cancer (IB3, IIA2) Patients","Inclusion Criteria:\n\n* Histologically confirmed cervical squamous cell carcinoma, cervical adenocarcinoma, or cervical adenosquamous carcinoma;\n* According to FIGO2018 staging, patients with locally advanced cervical cancer (IB3, IIA2) who require concurrent radiotherapy and chemotherapy;\n* Patients with radical surgery for cervical cancer;\n* Female patients: 18-70 years old;\n* ECOG physical condition score: 0\\~1 point;\n* Subjects have not received previous immunotherapy;\n* Expected survival ≥6 months;\n* Women of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the study ends; Have a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be a non-lactating patient;\n* For adequate organ function as defined in the protocol, test samples must be collected within 7 days prior to initiation of the study therapy\n* Subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up.\n\nExclusion Criteria:\n\n* Subjects have histological subtypes other than those permitted by inclusion criteria;\n* Severe hypersensitivity to cepalizumab and\u002For any of its excipients (≥ grade 3);\n* Participate in or have participated in other clinical trials within 4 weeks before enrollment;\n* Have received or will receive inactivated vaccine within 30 days prior to the first study treatment;\n* Received a combination of systemic immune stimulants, colony-stimulating factors, interferon, interleukin, and vaccine within 6 weeks or 5 half-lives (if shorter) prior to initial administration;\n* Have been diagnosed with an immune deficiency or are receiving chronic systemic steroid therapy (doses greater than 10mg daily equivalent of prednisone) or any other form of immunosuppressive therapy within 7 days prior to the first dose;\n* Have an active autoimmune disease in the past 2 years that requires systemic treatment (such as the use of disease-modulating drugs, corticosteroids, or immunosuppressive drugs);\n* Have a history of (non-infectious) pneumonia requiring steroid treatment or have a current (non-infectious) pneumonia;\n* An active infection requiring systematic treatment;\n* Known history of HIV infection;\n* A known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as detection of HCV RNA\\[qualitative\\]) infection;\n* Known active tuberculosis (TB; Tuberculosis) medical history;\n* Has received allogeneic tissue\u002Fsolid organ transplantation;\n* Suffering from central nervous system metastases such as brain metastases;\n* Patients with uncontrolled chest and abdominal fluid;\n* Patients with mobility disorders such as pathological fractures caused by tumor bone metastasis;\n* Insufficient hematopoietic function of bone marrow;\n* Abnormal liver;\n* Abnormal kidney;\n* Bleeding risk;\n* Cardiovascular and cerebrovascular abnormalities.","FEMALE","18 Years","70 Years",{"count":81,"type":82},24,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","Locally advanced cervical cancer (stage IB3, IIA2) patients with postoperative risk factors need better treatment. We initiated a clinical study to explore the effectiveness of adjuvant chemoradiotherapy followed by Zimberelimab for these patients.",[88],"Cervical Cancer","NOT_YET_RECRUITING","2023-11-27",{"date":92,"type":93},"2023-11-30","ACTUAL",{"date":95,"type":82},"2023-12-01",{"date":97,"type":82},"2029-12-01",{"name":5,"class":6}]