NCT06518434招募中2 期
A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Tumor size
研究概览
简要总结
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
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
- •Age =>18 yrs
- •Histologically proven hepatocellular carcinoma
- •Non-cirrhosis or Child Pugh A cirrhosis
- •Hepatic encephalopathy grade 0 or 1
- •Multidisciplinary treatment (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 if applicable
- •Signed informed consent
- •Language: Dutch or English
排除标准
- •Child Pugh B or C cirrhosis
- •Hepatic encephalopathy grade 2 or more
- •Previous systemic treatment for HCC
- •Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
- •Use of medicinal cannabis for other purposes
- •Contra-indications for medicinal cannabis oil:
- •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.
- •Patients with known psychotic disorders
- •Female patients who are pregnant or lactating
- •Patients (men or women) intending to start a family
- •Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil
研究组 & 干预措施
Cannabis oil
Experimental
Treatment with cannabis oil
干预措施: Medical Cannabis (Drug)
结局指标
主要结局
Tumor size
时间窗: 9 months
Tumor size based on RECIST and mRECIST criteria
次要结局
- Tumor markers(9 months)
- Tumor size(6 months)
- Quality of Life questionnaires(9 months)
研究者
Maarten Nijkamp
Principal Investigator
University Medical Center Groningen
研究点 (1)
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