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Clinical Trials in the Netherlands / NCT06518434
Recruiting Phase 2

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

NCT06518434 · tracked via the Priya Life Science Netherlands tracker
Phase
Phase 2
Started
2021-04-15
Last updated
2024-07-24

Condition(s) studied

Hepatocellular CarcinomaCannabis

Investigational drug(s) / intervention(s)

Medical Cannabis →

Medical Cannabis: Medical cannabis oil three times daily

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Groningen Groningen Netherlands Recruiting

More University Medical Center Groningen trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06518434 on ClinicalTrials.gov ↗ ← All trials in the Netherlands