A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age =>18 yrs
Histologically proven hepatocellular carcinoma
Non-cirrhosis or Child Pugh A cirrhosis
Hepatic encephalopathy grade 0 or 1
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Medical Cannabis
DrugMedical cannabis oil three times daily
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Cannabis oilExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tumor size
Tumor size based on RECIST and mRECIST criteria
Time frame
9 monthsSecondary outcomes
1
Tumor size
Tumor size based on RECIST and mRECIST criteria
Time frame
3 months2
Tumor size
Tumor size based on RECIST and mRECIST criteria
Time frame
6 months3
Tumor markers
Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)
Time frame
3 months4
Tumor markers
Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov