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

A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma

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

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