Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma
报名条件(概要)
- 年龄:18 Years – 70 Years
- 性别:不限
- 健康志愿者:不接受
完整入排标准请以官方页面为准。
开展国家/地区
China
药品与企业信息
其他名称:h-R3、BIOMAb EGFR
Drug: Nimotuzumab Experimental: Nimotuzumab arm Induction chemotherapy:Nimotuzumab 200mg will be given weekly for 6 cycles, started on day 1 of induction chemotherapy. Concurrent chemotherapy: Nimotuzumab 200mg/week in concurrent with IMRT. Adjuvant therapy: Nimotuzumab (200mg ) will be given every 3 weeks for 8 cycles. Active Comparator: Control Nimotuzumab 200mg/week in concurrent with IMRT .
其他名称:GEM
Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 2 cycles
其他名称:DDP
Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles. Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles.
其他名称:IMRT
Definitive IMRT of 68-78 Gy, 30-33 fractions, 5 fractions/week, 1 fraction/day
研发企业
试验官方登记的主要申办方;研究机构申办时会显示相应机构名称。
生产企业
Cisplatin
WG Critical Care, LLC
合作机构
- People's Hospital of BaiseUNKNOWN
- Second Affiliated Hospital of Guangzhou Medical University研究机构/其他
- People's Hospital of Guangxi Zhuang Autonomous Region研究机构/其他
- Guilin Medical University, China研究机构/其他
- LiuZhou People's Hospital研究机构/其他
- The First People's Hospital of QinzhouUNKNOWN
- Wuzhou Red Cross Hospital研究机构/其他
- Youjiang Medical College for Nationalities研究机构/其他
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业;生产企业仅取自美国上市原研药说明书所列企业(不含仿制药),不作推测;仅在其他国家上市的药品暂无法显示。
研究简介(原文)
Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Nimotuzumab has been granted approval for use in squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal cancer in different countries. This is a multi-center, randomized controlled trial, with the purpose to evaluate the therapeutic efficacy and safety of nimotuzumab combined with induction chemotherapy plus chemoradiation and adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma.
适应症
主动联系研究团队
总联系人(申办方/研究总部)
- Ying Lu, MD1786734840@qq.com+8607723815405
中国/港澳台研究中心
- People's Hospital of BaiseBaise City,Guangxi,China
- Affiliated Hospital of Youjiang Medical University for NationalitiesBaise City,Guangxi,China
- Guilin Medical University, ChinaGuilin,Guangxi,China
- Nanxishan Hospital of Guangxi Zhuang Autonomous RegionGuilin,Guangxi,China
- the Fourth Affiliated Hospital of Guangxi Medical UniversityLiuzhou,Guangxi,China
- Second Affiliated Hospital of Guangzhou Medical UniversityNanjing,Guangxi,China
问自己是否符合条件、如何预筛
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英文版(发给研究团队)
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma ClinicalTrials.gov Identifier: NCT05717790 Sponsor: Fourth Affiliated Hospital of Guangxi Medical University Investigational product: Nimotuzumab, Gemcitabine, Cisplatin, Intensity-modulated radiotherapy About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照(供您核对)
尊敬的研究团队: 我是一位来自中国的患者,希望咨询参加以下临床试验的可能: 研究名称:Concurrent and Adjuvant Nimotuzumab Combined With Induction Chemotherapy Plus Chemoradiation in Nasopharyngeal Carcinoma 试验编号:NCT05717790 申办方:Fourth Affiliated Hospital of Guangxi Medical University 研究药物:Nimotuzumab、Gemcitabine、Cisplatin、Intensity-modulated radiotherapy 我的基本情况: - 年龄:(请填写) - 性别:(请填写) - 确诊疾病与分期:(请填写) - 基因/标志物检测:暂无 - 既往及当前治疗:(请填写) - 体能状态(ECOG):未评估 - 目前所在城市:中国 - 可前往范围:(请填写) 想请教三个问题: 1. 我是否可能符合本研究的入组标准? 2. 哪个中心对我最方便可行?能否远程预筛? 3. 预筛需要准备哪些资料(病历、病理、影像、近期化验)? 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 (您的姓名) (您的邮箱/带国际区号的电话)
提示:请与主治医生一起发信——由医生署名的申请,回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复,两周无回音可礼貌追问一次。
下一步怎么做?
- 把本页信息带给您的主治医生,评估是否适合参加。
- 点击下方按钮打开官方注册页,查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜(通常有中文同声翻译服务可协助沟通)。