A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10% / CBD 5%) in untreatable advanced hepatocellular carcinoma patients
- Conditions
- Hepatocellular carcinoma
- Registration Number
- NL-OMON28248
- Lead Sponsor
- MCG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 20
Age =>18 yrs
- Histologically proven hepatocellular carcinoma
- 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 driving until 2 weeks after the titration period, if applicable
- Signed informed consent
- Language: Dutch or English
- 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:
o 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.
o Patients with known psychotic disorders
o Female patients who are pregnant or lactating
o Patients (men or women) intending to start a family
o Hypersensitivity to cannabinoids or any of the excipients of the cannabis oil
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Endpoint:<br>to study objective response rate (ORR) of cannabis oil (THC10% / CBD5%) in untreatable advanced HCC patients by assessing RECIST (Response Evaluation Criteria In Solid Tumors)and modified-RECIST (mRECIST) criteria 6 months after starting cannabis oil. <br>
- Secondary Outcome Measures
Name Time Method Secondary Endpoint(s): <br>a.to study objective response rate of cannabis oil in untreatable advanced HCC patients by assessing <br>-RECIST22 and mRECIST23 criteria at 3 and 9 months after starting cannabis oil.<br>-levels of the tumor markers alfa-fetoprotein (AFP) and des-gamma-carboxy-prothrombin (DCP) at 3, 6 and 9 months<br><br>b.to study quality of life at baseline, 3, 6 and 9 months using questionnaires EORTC-QLQ C30 and EORTC- QLQ HCC18<br><br>c. to compare cannabinoid receptor expression in the tumor (based on histology) between baseline and 6 months after treatment with cannabis oil. <br><br>d. to compare immune cell presence in: <br>-blood at time points baseline, 3, 6 and 9 months after treatment with cannabis oil. <br>-tumor tissue at time points baseline and 6 months after treatment with cannabis oil<br>