A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients

Summary

to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria

Eligibility

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

Conditions5

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