NCT06518434RecruitingPhase 2
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
Source: ClinicalTrials.gov · Last updated 24 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 28 Sept 2021
- Start date
- 15 Apr 2021
- Primary completion date
- 15 Apr 2027
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06518434
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 15 Apr 2021 to the primary completion date, 15 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous systemic treatment for HCC
Other illness
- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
- 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
Other
- Child Pugh B or C cirrhosis
- Hepatic encephalopathy grade 2 or more
- Use of medicinal cannabis for other purposes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.