Phase IV Clinical Trial of Nimotuzumab in the Treatment of Nasopharyngeal Carcinoma
试验速览
- 阶段
- 4 期
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
研究概览
简要总结
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.
详细描述
This clinical study is designed as an open, single group, multi-center, phase 4 clinical study to assess the safety of Nimotuzumab in the treatment of nasopharyngeal carcinoma and to provide a more reasonable basis for clinical drug programs.
Subjects who meet the inclusion/exclusion criteria are administered of Nimotuzumab based on medication instructions or adjusted by clinicians according to the treatment. In case of the progression of disease, unacceptable toxicity, withdrawal of the consent, or judgment by investigator that the treatment needs to be stopped, the treatment of Nimotuzumab is stopped.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically or cytologically confirmed nasopharyngeal carcinoma
- •Sex and age without limiting
- •Treatment without limiting
- •Subjects with reproductive potential (males and females) willing to use reliable means of contraception
- •Able and willing to give written informed consent and comply with the requirements of the study protocol
排除标准
- •Patients with severe allergies or idiosyncratic constitution
- •Women who are pregnant (determined by urine pregnancy test)or breast feeding
- •Any other severe complications or functional disorder of organ systems, which will affect the evaluation of safety of patients or will interfere with the test drug according to the researcher's point of view
研究组 & 干预措施
Nimotuzumab Injection
200mg,Once a week，Intravenous infusion over 60 minutes
干预措施: Nimotuzumab Injection (Drug)
结局指标
主要结局
To determine the safety of the treatment with Nimotuzumab(NCI Common Terminology Criteria for Adverse Events v4.03)
时间窗: up to 30 months
次要结局
未报告次要终点