hepatocellular carcinoma (liver cancer)
Conditions
Interventions
Medical cannabis oil: Transvamix oil containing 10% tetrahydrocannabinol (THC)
and 5% cannabidiol (CBD).
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: to study objective response rate (ORR) of cannabis oil (THC10% / CBD5%) in untreatable advanced HCC patients by assessing RECIST[14] and mRECIST [15] criteria 6 months after starting cannabis oil. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint(s): a. to study objective response rate of cannabis oil in untreatable advanced HCC patients by assessing - RECIST[14] and mRECIST[15] criteria at 3 and 9 months after starting cannabis oil. - levels of the tumor markers alfa-fetoprotein (AFP) and des-gamma-carboxy-prothrombin (DCP) at 3, 6 and 9 months b. to study quality of life at baseline, 3, 6 and 9 months using questionnaires EORTC-QLQ C30 and EORTC- QLQ HCC18 c. to compare cannabinoid receptor expression in the tumor (based on histology) between baseline and 6 months after treatment with cannabis oil. d. to compare immune cell presence (including T-cells) in: - blood at time points baseline, 3, 6 and 9 months after treatment with cannabis oil. * - tumor tissue at time points baseline and 6 months after treatment with cannabis oil * | — |
Countries
Netherlands
Outcome results
None listed