NCT02008539终止1 期
Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
研究概览
简要总结
To evaluate the safety and tolerability of MSC_apceth_101.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
- •Premature or scheduled termination of standard therapy
- •Progressive disease as clinically assessed by the investigator
- •Max. tumour lesion ≤ 5 cm
- •Adequate organ function
- •Ability of patient to understand character and individual consequences of clinical trial
- •Age ≥ 18 years
- •Written informed consent must be available before any study specific procedure is performed
排除标准
- •Patients with severe heart diseases
- •Clinical significant ischemic disease during the last 4 weeks before Visit 1
- •Severe lung disease
- •Symptomatic peritoneal carcinomatosis
- •Symptomatic pleural or pericardial effusion
- •Serious uncontrolled acute infections less than 3 weeks before Visit 1
- •Known dependency on alcohol or other drugs
- •Patients requiring corticoids in doses above the Cushing threshold
- •Known liver fibrosis or liver cirrhosis
- •Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
- •Female patient who is pregnant or breast feeding
- •Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose
研究组 & 干预措施
treatment arm
Experimental
干预措施: MSC_apceth_101 (Drug)
结局指标
主要结局
Safety and tolerability as indicated by Common Toxicity Criteria (CTC-AE) of the National Cancer Institute
时间窗: day 56 (+/- 7) in patient group 1 and day 29 (+/-3) in patient group 2
次要结局
未报告次要终点
研究者
研究点 (1)
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