The Phase II of Nimotuzumab in Combination With Radiotherapy for Esophageal Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 5
- 主要终点
- The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
研究概览
简要总结
Nimotuzumab (hR3) is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
详细描述
Clinical efficacy has been shown in adult with head and neck cancer. The phase II study assessed the efficacy and safety of the combination of Nimotuzumab administered concomitantly with radiotherapy in patients with esophageal cancer tumours.
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
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pathologically or cytology diagnosed phase II-III esophageal carcinoma or IV thoracic segments carcinoma with the supraclavicular lymph nodes metastasis.
- •with the measureable lesion of the newly diagnosed the esophageal carcinoma.
- •age 18-75 years old
- •Expect survival date ≥3 months
- •without serious diseases of important organs
- •signature in the inform consent.
排除标准
- •pregnant or breast-feeding women or using a prohibited contraceptive method.
- •with psychiatric diseases.
- •with serious diseases or uncontrolled infection.
- •with history of other tumors.
- •participation other clinical trials within 1 month prior to inclusion in the trial.
- •not the first antitumor treatment .
研究组 & 干预措施
Nimotuzumab group
Nimotuzumab+radiotherapy
干预措施: Nimotuzumab (Drug)
Nimotuzumab group
Nimotuzumab+radiotherapy
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
The rate of AE(adverse event) or toxicity ( Both acute and chronic toxicity will be evaluated.)
时间窗: 3 months
assement of advers event after using medication based TAAE evaluation form
次要结局
- Partial response (PR)(3 months)
- Complete response(3 months)
- Stable disease (SD)(3 months)
- Progressive disease (PD)(3 months)
- Median survival time (MST)(2 years)
- Overall survival (OS)(1 year,2 years)