NCT00405873终止2 期
A Prospective, Open, Single-arm, Multicenter Phase II Clinical Trial to Evaluate the Tumour Response and Safety in Patients With Advanced Primary Hepatocellular Carcinoma Treated With AMT2003
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and the safety of AMT2003 in cancer patients with advanced primary hepatocellular carcinoma
The primary endpoint is best overall response rate within 20 weeks after registration
详细描述
The study will include patients with advanced primary hepatocellular carcinoma refractory to standard therapy or for which no effective standard therapy exists.
The best overall response rate is the best response recorded from the start of treatment until disease progression / recurrence.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cancer confirmed by histology or cytology
- •At least one measurable lesion
- •Advanced disease refractory to standard therapy or for which no standard therapy exists
- •Life expectancy of at least 3 months
排除标准
- •Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
- •Body weight below 45 kg
- •Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
- •Confirmed diagnosis of HIV
- •Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
- •Chemotherapy or radiotherapy less than 4 weeks prior to entry
- •Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
- •Participation in a clinical trial less than 30 days prior to entry into study
研究组 & 干预措施
AMT2003
Experimental
干预措施: AMT2003 (Drug)
结局指标
主要结局
Best overall tumour response according to RECIST; within 20 weeks after registration; confirmation 6 +/- weeks later
时间窗: March 2010
次要结局
- Progression Free Survival (PFS) time(March 2010)
- Overall Survival (OS) time(March 2010)
- Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)(March 2010)
- Safety and Tolerability(March 2010)
研究者
研究点 (2)
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