Actively Recruiting
Phase 2a Study of Cannabis Oil THC 10% CBD 5% Treatment for Advanced Untreatable Liver Cancer Hepatocellular Carcinoma
Led by University Medical Center Groningen · Updated on 2024-07-24
20
Participants Needed
1
Research Sites
N/A
Total Duration
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
Research Team
M
M W Nijkamp, MD PhD
D
DJ A de Groot, MD PhD
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