NL-OMON28248尚未招募不适用
A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10% / CBD 5%) in untreatable advanced hepatocellular carcinoma patients
MCG0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Age =>18 yrs
- •- Histologically proven hepatocellular carcinoma
- •- MDT-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining
- •treatment for advanced HCC.
- •- Minimal life expectancy of 3 months
- •- Willing and able to attend follow-up examinations
- •- Willing to stop driving until 2 weeks after the titration period, if applicable
- •- Signed informed consent
- •- Language: Dutch or English
排除标准
- •- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the
- •- Use of medicinal cannabis for other purposes
- •- Contra-indications for medicinal cannabis oil:
- •o Patients who have experienced a myocardial infarction or clinically significant cardiac dysfunction within the
- •last 12 months or have had a cardiac disorder that, in the opinion of the investigator would have put the
- •participant at risk of a clinically significant arrhythmia or myocardial infarction.
- •o Patients with known psychotic disorders
- •o Female patients who are pregnant or lactating
- •o Patients (men or women) intending to start a family
- •o Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil
研究者
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