NL-OMON49322招募中2 期
A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10% / CBD 5%) in patients with untreatable advanced hepatocellular carcinoma - CanHep study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 年龄范围
- 18 至 99（—）
入选标准
- •- Age =>18 yrs
- •- Histologically proven hepatocellular carcinoma
- •- Non-cirrhosis or Child-Pugh A cirrhosis
- •- Hepatic encephalopathy grade 0 or 1
- •- 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 active traffic participation or controlling machinery during
- •the study period, when 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 trial
- •- Use of medicinal cannabis for other purposes
- •- Child-Pugh B or C cirrhosis
- •- Hepatic encephalopathy grade 2 or more
- •- Previous systemic treatment for HCC
- •- 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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