[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100541742":3},{"organization":4,"outcomesModule":7,"designInfo":53,"detailedDescription":64,"studyPopulation":52,"armGroups":65,"interventions":80,"overallOfficials":104,"centralContacts":230,"locations":52,"responsibleParty":239,"collaborators":52,"id":241,"slug":52,"hasResults":242,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":52,"eligibilityCriteria":246,"healthyVolunteers":242,"sex":247,"minAge":248,"maxAge":249,"enrollmentInfo":250,"targetDuration":52,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":52,"overallStatus":259,"whyStopped":52,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":52},{"fullName":5,"class":6},"Biotech Pharmaceutical Co., Ltd.","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":52},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR)","PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.","Up to approximately 5 years",[14,16,20,23,26,29,33,36,38,41,45,48],{"measure":15,"description":11,"timeFrame":12},"Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator",{"measure":17,"description":18,"timeFrame":19},"3-,5-Year Overall Survival (OS)","OS is the time from randomization to death due to any cause.","Up to approximately 3 and 5 years",{"measure":21,"description":22,"timeFrame":19},"3-,5-Year Disease Free Survival(DFS)","DFS is defined as the time from randomization to disease recurrence or death due to any cause.",{"measure":24,"description":25,"timeFrame":19},"3-,5-Year Locoregional Recurrence-Free Survival(LRRFS)","Locoregional recurrence-free survival (LRRFS) was defined as the absence of either consistent or relapsed disease at the primary tumor site or the regional lymph nodes",{"measure":27,"description":28,"timeFrame":19},"3-,5-Year Distant Metastasis-free Survival (DMFS)","Distant metastasis-free survival (DMFS) was calculated from the date of patient recruitment to the date of distant metastasis.",{"measure":30,"description":31,"timeFrame":32},"Tumor Regression Rate(TRR)","The maximum diameter represents the size of the tumor by MRI. Tumor size for each patient were obtained: pre-RT tumor size (V1), pre- brachytherapy tumor size (V2). TRR=(V1-V2)\u002FV1 × 100%.","From date of randomization until the date of brachytherapy,assessed up to 5 weeks",{"measure":34,"description":35,"timeFrame":32},"Complete Response Rate","The proportion of subjects with the best complete response in this group assessed by MRI.",{"measure":34,"description":35,"timeFrame":37},"3 months later after treatment",{"measure":39,"description":40,"timeFrame":37},"Objective Response Rate","The proportion of subjects with the best complete response or partial response in this group assessed by MRI.",{"measure":42,"description":43,"timeFrame":44},"Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status Score","The EORTC QLQ-C30 is a questionnaire that rates the overall quality of life in cancer participants. The first 28 questions use a 4-point scale (1=not at all to 4=very much) for evaluating function (physical, role, social, cognitive, emotional), symptoms (diarrhea, fatigue, dyspnea, appetite loss, insomnia, nausea\u002Fvomiting, constipation, and pain) and financial difficulties. The last 2 questions use a 7-point scale (1=very poor to 7=excellent) to evaluate overall health and quality of life. Global scores are converted to a score of 0 to 100, with a higher score indicating improved health status. The change from baseline in EORTC QLQ-C30 score will be presented.","Baseline and up to approximately 5 years",{"measure":46,"description":47,"timeFrame":44},"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","The EORTC QLQ-CX24 is a questionnaire that rates the symptoms common to women with cervical cancer and evaluates the impact of disease and\u002For treatments. The 24 items use a 4-point scale (1=not at all to 4=very much) and are classified into 3 multi-item scales, 11 items with symptom experience, 3 items with body image, and 4 items with sexual\u002F vaginal functioning. The other items of the questionnaire are lymphedema, peripheral neuropathy, menopausal symptom, sexual worry, sexual activity, and sexual enjoyment. The change from baseline in EORTC QLQ-CX24 score will be presented.",{"measure":49,"description":50,"timeFrame":51},"Incidence of Treatment-Emergent Adverse Events","Safety was assessed as adverse events during treatment, the incidence of various adverse events such as adverse events related to the study drug during treatment, laboratory tests, etc","Within 30 days from the start of treatment to the end of the last treatment",null,{"allocation":54,"interventionModel":55,"interventionModelDescription":56,"primaryPurpose":57,"observationalModel":52,"timePerspective":52,"maskingInfo":58},"RANDOMIZED","PARALLEL","This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III trial","TREATMENT",{"masking":59,"maskingDescription":60,"whoMasked":61},"DOUBLE","This study is double-blind and will blind both the investigator and the subjects. All participants in the study (including data managers and biostatisticians) will be unaware of treatment assignment (except blind statisticians).",[62,63],"PARTICIPANT","INVESTIGATOR","This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical study.The trail will enroll 460 subjects (FIGO 2018, stageIB3-IVA)who meet enrollment criteria but do not meet exclusion criteria. According to clinical stage (FIGO 2018 stage, stage IB3-IIB or III-IVA) 、tumor diameter (\\>4cm or ≤4cm)、 age (≥18 years and \\\u003C 65 years old or ≥65 years old and ≤80 years old) for stratified randomization. They are divided into experimental group and control group according to 1:1. Patients in the experimental group will receive nimotuzumab 400mg on the basis of concurrent chemoradiotherapy, once a week for 7-8 weeks, and then maintenance treatment once every 2 weeks for 24 weeks. Using placebo(Nimotuzumab injection mimics) in the control group 80 ml on the basis of concurrent chemoradiotherapy, once a week for 7 to 8 weeks, after the maintenance treatment, once every 2 weeks for 24 weeks. Patients with incomplete tumor response assessed by imaging and pathological examination 3 months after radiotherapy can be given 2-4 cycles of adjuvant chemotherapy with cisplatin\u002Fcarboplatin combined with paclitaxel regimen. Regular imaging examination and survival follow-up were performed after treatment. The primary efficacy end point was progression-free survival.",[66,75],{"label":67,"type":68,"description":69,"interventionNames":70},"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 .",[71,72,73,74],"Biological: Nimotuzumab","Drug: Cisplatin","Radiation: External Beam Radiotherapy (EBRT)","Radiation: Brachytherapy",{"label":76,"type":68,"description":77,"interventionNames":78},"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 .",[72,73,74,79],"Drug: placebo for Nimotuzumab",[81,86,91,95,98],{"type":82,"name":83,"description":84,"armGroupLabels":85,"otherNames":52},"BIOLOGICAL","Nimotuzumab","Nimotuzumab 400mg",[67],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":52},"DRUG","Cisplatin","Cisplatin 40mg\u002Fm\\^2",[67,76],{"type":92,"name":93,"description":93,"armGroupLabels":94,"otherNames":52},"RADIATION","External Beam Radiotherapy (EBRT)",[67,76],{"type":92,"name":96,"description":96,"armGroupLabels":97,"otherNames":52},"Brachytherapy",[67,76],{"type":87,"name":99,"description":100,"armGroupLabels":101,"otherNames":102},"placebo for Nimotuzumab","placebo for Nimotuzumab 400mg",[76],[103],"placebo",[105,109,112,115,118,121,124,127,130,133,136,139,142,145,147,150,153,156,159,162,165,168,171,174,177,180,183,186,189,192,195,198,201,204,207,210,213,216,219,222,225,228],{"name":106,"affiliation":107,"role":108},"Junjie Wang","Peking University Third Hospital","STUDY_CHAIR",{"name":110,"affiliation":111,"role":108},"Lichun Wei","TThe First Affiliated Hospital，the Air Force Medical University",{"name":113,"affiliation":114,"role":108},"Lijuan Zou","The Second Affiliated Hospital of Dalian Medical University",{"name":116,"affiliation":117,"role":108},"Zi Liu","First Affiliated Hospital Xi'an Jiaotong University",{"name":119,"affiliation":120,"role":108},"Jiayi Chen","Ruijin Hospital",{"name":122,"affiliation":123,"role":108},"Huijun Cheng","Henan Cancer Hospital",{"name":125,"affiliation":126,"role":108},"Rutie Yin","West China Second University Hospital",{"name":128,"affiliation":129,"role":108},"Xiangkun Yuan","Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine.HeBei",{"name":131,"affiliation":132,"role":108},"Hui Qiu","Zhongnan Hospital",{"name":134,"affiliation":135,"role":108},"Hong Zhu","Xiangya Hospital of Central South University",{"name":137,"affiliation":138,"role":108},"Tiejun Wang","Second Hospital of Jilin University",{"name":140,"affiliation":141,"role":108},"Xiaomei Fan","The Fourth Hospital of Hebei Medical University Hebei Tumor Hospital",{"name":143,"affiliation":144,"role":108},"Keqiang Zhang","Hunan Cancer Hospital",{"name":146,"affiliation":144,"role":108},"Dihong Tang",{"name":148,"affiliation":149,"role":108},"Qiongyu Lan","Second Affiliated Hospital of Nanchang University",{"name":151,"affiliation":152,"role":108},"Xiaoying Xue","The Second Hospital of Hebei Medical University",{"name":154,"affiliation":155,"role":108},"Song Gao","Shengjing Hospital",{"name":157,"affiliation":158,"role":108},"Guang Li","First Hospital of China Medical University",{"name":160,"affiliation":161,"role":108},"Qiuhong Tian","The First Affiliated Hospital of Nanchang University",{"name":163,"affiliation":164,"role":108},"Guoqing Wang","Shanxi Province Cancer Hospital",{"name":166,"affiliation":167,"role":108},"Dong Qian","The First Affiliated Hospital of USTC (Anhui Provincial Hospital)",{"name":169,"affiliation":170,"role":108},"Manbo Cai","The First Affiliated Hospital of University of South China",{"name":172,"affiliation":173,"role":108},"Yuhua Gao","Liaoning Cancer Hospital & Institute",{"name":175,"affiliation":176,"role":108},"Dehua Wu","Nanfang Hospital, Southern Medical University",{"name":178,"affiliation":179,"role":108},"Xiaoge Sun","The Affiliated Hospital of Inner Mongolia Medical University",{"name":181,"affiliation":182,"role":108},"Yunyan Zhang","Cancer Hospital Affiliated to Harbin Medical University",{"name":184,"affiliation":185,"role":108},"Kun Gao","Guangxi Medical University Cancer Center",{"name":187,"affiliation":188,"role":108},"Qin Lin","The First Affiliated Hospital of Xiamen University",{"name":190,"affiliation":191,"role":108},"Qin Xu","Fujian Cancer Hospital",{"name":193,"affiliation":194,"role":108},"Hao Yang","Peking University Cancer Hospital Inner Mongolia Hospital",{"name":196,"affiliation":197,"role":108},"Rong Huang","First People's Hospital of Foshan",{"name":199,"affiliation":200,"role":108},"Xianming Li","Shenzhen People's Hospital",{"name":202,"affiliation":203,"role":108},"Juntao Ran","LanZhou University",{"name":205,"affiliation":206,"role":108},"Xiaojie Ma","Affiliated Hospital of North Sichuan Medical College",{"name":208,"affiliation":209,"role":108},"Xingrao Wu","Yunnan Cancer Hospital",{"name":211,"affiliation":212,"role":108},"Yipeng Song","Yantai Yuhuangding Hospital",{"name":214,"affiliation":215,"role":108},"Jun Wang","Tianjin Cancer Hospital Airport Hospital",{"name":217,"affiliation":218,"role":108},"Dapeng Li","Shandong Cancer Hospital ＆ Institute",{"name":220,"affiliation":221,"role":108},"Siyuan Zeng","Jiangxi Maternal and Child Health Hospital",{"name":223,"affiliation":224,"role":108},"Hongyun Shi","Affiliated Hospital of Hebei University",{"name":226,"affiliation":227,"role":108},"Weihu Wang","Peking University Cancer Hospital & Institute",{"name":229,"affiliation":164,"role":108},"Jidong Zhang",[231,235],{"name":106,"role":232,"phone":233,"phoneExt":52,"email":234},"CONTACT","13701076310","junjiewang_edu@sina.cn",{"name":236,"role":232,"phone":237,"phoneExt":52,"email":238},"Ping Jiang","13439796018","drjiangping@qq.com",{"type":240,"investigatorFullName":52,"investigatorTitle":52,"investigatorAffiliation":52,"oldNameTitle":52,"oldOrganization":52},"SPONSOR","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":251,"type":252},460,"ESTIMATED","INTERVENTIONAL",[255],"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.",[258],"Cervical Cancer","NOT_YET_RECRUITING","2024-03-20",{"date":262,"type":263},"2024-03-27","ACTUAL",{"date":265,"type":252},"2024-04-01",{"date":267,"type":252},"2030-04-01",{"name":5,"class":6}]