[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525955":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":32,"centralContacts":37,"locations":22,"responsibleParty":43,"collaborators":22,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":22,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":22,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":22,"overallStatus":65,"whyStopped":22,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":22},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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",[13,14,15],"Drug: Zimberelimab","Drug: Platinum","Radiation: radiotherapy",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Zimberelimab","240mg, q3w，8 cycles",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Platinum","cisplatin 40mg\u002Fm2 for 5-6 cycles",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":22},"RADIATION","radiotherapy","45-50Gy\u002F1.8Gy\u002F25-28f",[9],[33],{"name":34,"affiliation":35,"role":36},"Keqin Hua, Doctor","Gynecology and obstetrics hospital of fudan university","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Junjun Qiu, Doctor","CONTACT","18017738139","qiujunjun1113@163.com",{"type":36,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Keqin Hua","Director of Gynecological Oncology","100525955","phase-2-adjuvant-chemoradiotherapy-followed-by-zimberelimab-for-locally-advanced-cervical-cancer-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":57,"type":58},24,"ESTIMATED","INTERVENTIONAL",[61],"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.",[64],"Cervical Cancer","NOT_YET_RECRUITING","2023-11-27",{"date":68,"type":69},"2023-11-30","ACTUAL",{"date":71,"type":58},"2023-12-01",{"date":73,"type":58},"2029-12-01",{"name":5,"class":6}]