NCT00950417已完成1 期
Phase I Study of Nimotuzumab in Combination With Simultaneous Chemotherapy and Radiation for Patients With Locally Advanced Esophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety and toxicity of this new treatment. 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 I study assessed the safety, and efficacy of the combination of Nimotuzumab administered concomitantly with chemo-radiotherapy in patients with locally advanced esophageal cancer tumours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Informed consent form signed before performing any of the study's specific procedures.
- •ECOG performance status 0-
- •Age > 18 and <
- •Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria, greater than or equal to 1 cm (longest diameter) by spiral computed tomography (CT) scan and MRI or greater than or equal to 2 cm by other ordinary radiographic technique.
- •Histologically confirmed diagnosis of locally advanced esophageal.
- •Life expectancy of more than 3 months.
- •Use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy.
- •No serious blood producing,abnormal function of heart,lung, liver, or kidney or immuno-deficiency
- •Neutrophils ≥3×109/L, platelet count≥100×109/L and haemoglobin≥9g/dL ,Creatinine ≤ 1.5 x NUL
排除标准
- •Previous radiotherapy or chemotherapy
- •Pregnant or breast-feeding women
- •Drug abuse, unhealthy drug/alcohol addiction,or virus (HIV) infection
- •Evidence of distant metastasis
- •Participation in other clinical trials
- •Patients with aphthosis, complete obstruction, fistula or deep peptic ulcer in the esophagus, or haematemesis
- •Uncontrolled psychiatric disease or seizure
- •Patients not fit for the clinical trial judged by the investigators
研究组 & 干预措施
Esophageal Cancer
Experimental
干预措施: Nimotuzumab (Drug)
结局指标
主要结局
Safety and toxicity of this new treatment. Both acute and chronic toxicity will be evaluated.
时间窗: within study period
次要结局
- To determine the complete response rate、partial rate、disease responserate、disease control rate in the patients subject to treatment(6 months)
研究者
研究点 (1)
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