Status:
RECRUITING
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
Lead Sponsor:
University Medical Center Groningen
Conditions:
Hepatocellular Carcinoma
Cannabis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 15 2027
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06518434
Start Date
April 15 2021
End Date
April 15 2027
Last Update
July 24 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ