Effect of cannabis oil on untreatable liver cancer
A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
This study tests whether cannabis oil can help people with untreatable liver cancer feel better by seeing if it affects their tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06518434 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the anti-tumor effects of cannabis oil containing THC and CBD in patients with untreatable hepatocellular carcinoma (HCC). The study will assess the efficacy of the treatment using mRECIST and RECIST criteria to evaluate tumor response. Participants will receive best supportive care while being monitored for any changes in their condition. The study aims to provide insights into the potential role of cannabis oil in managing advanced liver cancer.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed hepatocellular carcinoma who are unable to undergo standard treatments.
Not a fit: Patients with advanced cirrhosis (Child Pugh B or C) or significant hepatic encephalopathy are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new therapeutic option for patients with advanced liver cancer who have limited treatment choices.
How similar studies have performed: While the use of cannabis oil in cancer treatment is being explored, this specific approach in untreatable liver cancer is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Groningen
- University Medical Center Groningen — Groningen, Netherlands (Recruiting)
Study contacts
- Principal investigator: M W Nijkamp, MD PhD — University Medical Center Groningen
- Study coordinator: M W Nijkamp, MD PhD
- Email: m.w.nijkamp@umcg.nl
- Phone: +31625649985
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.