Actively Recruiting
A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
Led by University Medical Center Groningen · Updated on 2024-07-24
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the anti-tumor effects of cannabis oil containing THC 10% and CBD 5% in patients with advanced hepatocellular carcinoma (HCC) that cannot be treated by other means. This Phase 2a study focuses on measuring tumor size changes using mRECIST and RECIST criteria to understand how cannabis oil may affect untreatable liver cancer. Participants will receive medical cannabis oil three times daily as the investigational treatment. The study does not include a comparison group or placebo. It is designed to observe how the tumor responds over time with treatment, assessing tumor size and tumor markers at different intervals. During the study, participants will undergo evaluations at 3, 6, and 9 months, including tumor size measurements, tumor marker tests, and Quality of Life questionnaires. Researchers will monitor the anti-tumor effect primarily by tumor size at 9 months. Participants must be able to attend follow-up visits and comply with study requirements, including possible restrictions on activities like driving during the treatment period.
CONDITIONS
Brief Title
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically proven hepatocellular carcinoma
- Non-cirrhosis or Child Pugh A cirrhosis
- Hepatic encephalopathy grade 0 or 1
- Advised best supportive care for untreatable advanced HCC or unable/declining treatment
- 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 if applicable
- Signed informed consent
- Language: Dutch or English
You will not qualify if you...
- Child Pugh B or C cirrhosis
- Hepatic encephalopathy grade 2 or higher
- Previous systemic treatment for hepatocellular carcinoma
- Mental conditions preventing understanding of the trial
- Use of medicinal cannabis for other purposes
- Recent myocardial infarction or significant cardiac dysfunction within 12 months
- Known psychotic disorders
- Pregnant or lactating female patients
- Patients intending to start a family
- Hypersensitivity to cannabinoids or cannabis oil excipients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 9 months
Participants receive cannabis oil three times daily as treatment for advanced untreatable hepatocellular carcinoma.
Visits approximately at 3, 6, and 9 months for assessments
Trial Site Locations
Total: 1 location
1
University Medical Center Groningen
Groningen, Netherlands, 9713 GZ
Actively Recruiting
Research Team
M
M W Nijkamp, MD PhD
D
DJ A de Groot, MD PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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