Recruiting NCT06518434
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Medical Cannabis.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Cannabis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
Overview
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Interventions
- Drug Medical Cannabis
Medical cannabis oil three times daily
Primary outcome measures
- Tumor size [Time frame: 9 months]
Secondary outcome measures (8)
- Tumor size [Time frame: 3 months]
- Tumor size [Time frame: 6 months]
- Tumor markers [Time frame: 3 months]
- Tumor markers [Time frame: 6 months]
- Tumor markers [Time frame: 9 months]
- Quality of Life questionnaires [Time frame: 3 months]
- Quality of Life questionnaires [Time frame: 6 months]
- Quality of Life questionnaires [Time frame: 9 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- University Medical Center Groningen — Groningen
Identifiers
NCT: NCT06518434 · 201800881