[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541742":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":47,"centralContacts":173,"locations":28,"responsibleParty":182,"collaborators":28,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":28,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":193,"enrollmentInfo":194,"targetDuration":28,"studyType":197,"phases":198,"briefSummary":200,"conditions":201,"keywords":28,"overallStatus":203,"whyStopped":28,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":28},{"fullName":5,"class":6},"Biotech Pharmaceutical Co., Ltd.","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Nimotuzumab+chemoradiotherapy","EXPERIMENTAL","Participants receive Nimotuzumab 400 mg intravenously (IV) on Day 1 of each week cycle (QW) for 7-8 cycles followed by Nimotuzumab 400 mg IV on Day 1 of each 2-week cycle (Q2W) for an additional 12 cycles. During the QW dosing period of Nimotuzumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg\u002Fm\\^2 IV once or divides into 3 times per week (QW) for 4 or 5 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80-85 Gray Units (Gy) for volume-directed given with the total duration of radiation treatment not to exceed 8 weeks .",[13,14,15,16],"Biological: Nimotuzumab","Drug: Cisplatin","Radiation: External Beam Radiotherapy (EBRT)","Radiation: Brachytherapy",{"label":18,"type":10,"description":19,"interventionNames":20},"placebo for Nimotuzumab+chemoradiotherapy","Participants receive placebo for Nimotuzumab 400 mg intravenously (IV) on Day 1 of each week cycle (QW) for 7-8 cycles followed by placebo 400 mg IV on Day 1 of each 2-week cycle (Q2W) for an additional 12 cycles. During the QW dosing period of placebo, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg\u002Fm\\^2 IV once or divides into 3 times per week (QW) for 4 or 5 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy with minimum total radiotherapy dose of 80-85 Gray Units (Gy) for volume-directed given with the total duration of radiation treatment not to exceed 8 weeks .",[14,15,16,21],"Drug: placebo for Nimotuzumab",[23,29,34,38,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","Nimotuzumab","Nimotuzumab 400mg",[9],null,{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":28},"DRUG","Cisplatin","Cisplatin 40mg\u002Fm\\^2",[9,18],{"type":35,"name":36,"description":36,"armGroupLabels":37,"otherNames":28},"RADIATION","External Beam Radiotherapy (EBRT)",[9,18],{"type":35,"name":39,"description":39,"armGroupLabels":40,"otherNames":28},"Brachytherapy",[9,18],{"type":30,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"placebo for Nimotuzumab","placebo for Nimotuzumab 400mg",[18],[46],"placebo",[48,52,55,58,61,64,67,70,73,76,79,82,85,88,90,93,96,99,102,105,108,111,114,117,120,123,126,129,132,135,138,141,144,147,150,153,156,159,162,165,168,171],{"name":49,"affiliation":50,"role":51},"Junjie Wang","Peking University Third Hospital","STUDY_CHAIR",{"name":53,"affiliation":54,"role":51},"Lichun Wei","TThe First Affiliated Hospital，the Air Force Medical University",{"name":56,"affiliation":57,"role":51},"Lijuan Zou","The Second Affiliated Hospital of Dalian Medical University",{"name":59,"affiliation":60,"role":51},"Zi Liu","First Affiliated Hospital Xi'an Jiaotong University",{"name":62,"affiliation":63,"role":51},"Jiayi Chen","Ruijin Hospital",{"name":65,"affiliation":66,"role":51},"Huijun Cheng","Henan Cancer Hospital",{"name":68,"affiliation":69,"role":51},"Rutie Yin","West China Second University Hospital",{"name":71,"affiliation":72,"role":51},"Xiangkun Yuan","Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine.HeBei",{"name":74,"affiliation":75,"role":51},"Hui Qiu","Zhongnan Hospital",{"name":77,"affiliation":78,"role":51},"Hong Zhu","Xiangya Hospital of Central South University",{"name":80,"affiliation":81,"role":51},"Tiejun Wang","Second Hospital of Jilin University",{"name":83,"affiliation":84,"role":51},"Xiaomei Fan","The Fourth Hospital of Hebei Medical University Hebei Tumor Hospital",{"name":86,"affiliation":87,"role":51},"Keqiang Zhang","Hunan Cancer Hospital",{"name":89,"affiliation":87,"role":51},"Dihong Tang",{"name":91,"affiliation":92,"role":51},"Qiongyu Lan","Second Affiliated Hospital of Nanchang University",{"name":94,"affiliation":95,"role":51},"Xiaoying Xue","The Second Hospital of Hebei Medical University",{"name":97,"affiliation":98,"role":51},"Song Gao","Shengjing Hospital",{"name":100,"affiliation":101,"role":51},"Guang Li","First Hospital of China Medical University",{"name":103,"affiliation":104,"role":51},"Qiuhong Tian","The First Affiliated Hospital of Nanchang University",{"name":106,"affiliation":107,"role":51},"Guoqing Wang","Shanxi Province Cancer Hospital",{"name":109,"affiliation":110,"role":51},"Dong Qian","The First Affiliated Hospital of USTC (Anhui Provincial Hospital)",{"name":112,"affiliation":113,"role":51},"Manbo Cai","The First Affiliated Hospital of University of South China",{"name":115,"affiliation":116,"role":51},"Yuhua Gao","Liaoning Cancer Hospital & Institute",{"name":118,"affiliation":119,"role":51},"Dehua Wu","Nanfang Hospital, Southern Medical University",{"name":121,"affiliation":122,"role":51},"Xiaoge Sun","The Affiliated Hospital of Inner Mongolia Medical University",{"name":124,"affiliation":125,"role":51},"Yunyan Zhang","Cancer Hospital Affiliated to Harbin Medical University",{"name":127,"affiliation":128,"role":51},"Kun Gao","Guangxi Medical University Cancer Center",{"name":130,"affiliation":131,"role":51},"Qin Lin","The First Affiliated Hospital of Xiamen University",{"name":133,"affiliation":134,"role":51},"Qin Xu","Fujian Cancer Hospital",{"name":136,"affiliation":137,"role":51},"Hao Yang","Peking University Cancer Hospital Inner Mongolia Hospital",{"name":139,"affiliation":140,"role":51},"Rong Huang","First People's Hospital of Foshan",{"name":142,"affiliation":143,"role":51},"Xianming Li","Shenzhen People's Hospital",{"name":145,"affiliation":146,"role":51},"Juntao Ran","LanZhou University",{"name":148,"affiliation":149,"role":51},"Xiaojie Ma","Affiliated Hospital of North Sichuan Medical College",{"name":151,"affiliation":152,"role":51},"Xingrao Wu","Yunnan Cancer Hospital",{"name":154,"affiliation":155,"role":51},"Yipeng Song","Yantai Yuhuangding Hospital",{"name":157,"affiliation":158,"role":51},"Jun Wang","Tianjin Cancer Hospital Airport Hospital",{"name":160,"affiliation":161,"role":51},"Dapeng Li","Shandong Cancer Hospital ＆ Institute",{"name":163,"affiliation":164,"role":51},"Siyuan Zeng","Jiangxi Maternal and Child Health Hospital",{"name":166,"affiliation":167,"role":51},"Hongyun Shi","Affiliated Hospital of Hebei University",{"name":169,"affiliation":170,"role":51},"Weihu Wang","Peking University Cancer Hospital & Institute",{"name":172,"affiliation":107,"role":51},"Jidong Zhang",[174,178],{"name":49,"role":175,"phone":176,"phoneExt":28,"email":177},"CONTACT","13701076310","junjiewang_edu@sina.cn",{"name":179,"role":175,"phone":180,"phoneExt":28,"email":181},"Ping Jiang","13439796018","drjiangping@qq.com",{"type":183,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100541742","phase-3-a-study-of-nimotuzumab-plus-concurrent-chemoradiotherapy-sequential-maintenance-treatment-for-cervical-carcinoma-100541742",false,"NCT06333821","A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma","A Multicentre, Prospective, Randomized, Double-blind, Placebo-controlled Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Locally Advanced Cervical Squamous Cell Carcinoma","Inclusion Criteria:\n\n* 1.Aged 18-80 years old;\n* 2.Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);\n* 3.At least one measurable lesion according to RECIST 1.1;\n* 4.Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria: Hemoglobin ≥ 90 g\u002FL; Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL and white blood cell count ≥ 3.0 × 10\\^9\u002FL; Platelet count ≥ 100 × 10\\^9\u002FL; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN ; Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;\n* 5.ECOG score 0-1 points;\n* 6.Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation); Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;\n* 7.Compliance is good and informed consent is voluntarily signed.\n\nExclusion Criteria:\n\n* 1.Cervical adenocarcinoma and rare pathological types of malignant tumors;\n* 2.Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;\n* 3.Ureteral obstruction, inability to place ureteral stent or pyelostomy;\n* 4.Pregnant or lactating women;\n* 5.Patients with rectovaginal fistula\u002Fvaginovesical fistula\u002Funcontrolled vaginal bleeding or at risk of fistula;\n* 6.Had undergone major surgery (except biopsy) within 4 weeks prior to randomization;\n* 7.Had received a live vaccine within 4 weeks prior to the initial study drug treatment or planned to vaccinate during the study;\n* 8.Human immunodeficiency virus (HIV) infection;Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);\n* 9.Had the following serious medical conditions: a) Uncontrolled hypertension (defined as systolic blood pressure \\> 150 mmHg or diastolic blood pressure \\> 100 mmHg), or had experienced a hypertensive crisis; b) Myocardial infarction and unstable angina occurred within 6 months before randomization; c) Decompensated heart failure within three months before enrollment (NYHA class III and IV); d) The presence of severe arrhythmias requiring long-term medical intervention, except in patients with asymptomatic atrial fibrillation with stable ventricular rate; e) Left ventricular ejection fraction (LVEF)\\\u003C50%; f) The presence of uncontrolled hyperglycemia; g) The presence of uncontrollable infections；\n* 10.The presence of active or suspected autoimmune diseases, except for type 1 diabetes、hypothyroidism or skin conditions that do not require systemic treatment (vitiligo、psoriasis or alopecia)；\n* 11.Conditions requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days before randomization；\n* 12.Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);\n* 13.Patients with Crohn's disease and ulcerative colitis;\n* 14.Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;\n* 15.Patients with known hypersensitivity to Nimotuzumab or its components;\n* 16.Patients with contraindications to cisplatin、carboplatin and paclitaxel;\n* 17.Patients with neurological or psychiatric disorders affecting cognitive ability;\n* 18.Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;\n* 19.Any condition that, in the opinion of the Investigator, may be inappropriate for patients in the study.","FEMALE","18 Years","80 Years",{"count":195,"type":196},460,"ESTIMATED","INTERVENTIONAL",[199],"PHASE3","The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.\n\nThe primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.",[202],"Cervical Cancer","NOT_YET_RECRUITING","2024-03-20",{"date":206,"type":207},"2024-03-27","ACTUAL",{"date":209,"type":196},"2024-04-01",{"date":211,"type":196},"2030-04-01",{"name":5,"class":6}]