๐ฌIn plain words
What the trial is, and whether it could suit you
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
University Medical Center Groningen
Groningen, Netherlands
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.