Cannabis, Hepatocellular Carcinoma
Conditions
Brief summary
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Interventions
DRUGMedical Cannabis
Medical cannabis oil three times daily
Sponsors
University Medical Center Groningen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor size | 9 months | Tumor size based on RECIST and mRECIST criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor size | 3 months | Tumor size based on RECIST and mRECIST criteria |
| Tumor markers | 3 months | Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT) |
| Quality of Life questionnaires | 3 months | EORTC-QLQ30 and -HCC18 |
Countries
Netherlands
Contacts
Primary ContactM W Nijkamp, MD PhD
Backup ContactDJ A de Groot, MD PhD
Outcome results
None listed