NCT01935453已完成1 期
A Phase I Study of Recombinant hGM-CSF Herpes Simplex Virus
OrienGene Biotechnology Ltd.2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03
研究概览
简要总结
The main purpose of this study is to study the safety of OrienX010 in the treatment of kinds of solid tumors such as melanoma,liver cancer,pancreatic cancer and lung cancer.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients in advanced stage of malignant tumor diagnosticated by pathologic and cytological analysis.
- •lack of routine effective treatment,failure of routine treatment or relapse
- •age of 18-70,ECOG 0-2 and estimated survival is above 3 months
- •had an interval of above 4 weeks since exposure to chemotherapy or radiotherapy and above 6 weeks since exposure to nitrosoureas or mitomycin C.
排除标准
- •Serious internal diseases
- •uncontrolled primary and metastatic brain tumor
- •sizes of tumor does not meet the requirement of injection
结局指标
主要结局
Exploring the MTD of OrienX010 according to DLT,which defined as the serious degree of adverse events relates to the medicine not less than grade 3 of CTCAE v4.03
时间窗: 28 days after the last administration
次要结局
- Using RECIST 1.1 to evaluate the preliminary efficacy of OrienX010(28 days after the last administration)
研究者
研究点 (2)
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