A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10% / CBD 5%) in patients with untreatable advanced hepatocellular carcinoma

Phase 2

Recruiting

Conditions: hepatocellular carcinoma (liver cancer)
10019815

Registration Number: NL-OMON49322

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Age =>18 yrs
- Histologically proven hepatocellular carcinoma
- Non-cirrhosis or Child-Pugh A cirrhosis
- Hepatic encephalopathy grade 0 or 1
- 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, when applicable
- Signed informed consent
- Language: Dutch or English

Exclusion Criteria

- Mental conditions rendering the subject incapable to understand the nature,
scope and consequences of the trial
- Use of medicinal cannabis for other purposes
- Child-Pugh B or C cirrhosis
- Hepatic encephalopathy grade 2 or more
- Previous systemic treatment for HCC
- 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
<p>Primary Endpoint:<br /><br>to study objective response rate (ORR) of cannabis oil (THC10% / CBD5%) in<br /><br>untreatable advanced HCC patients by assessing RECIST[14] and mRECIST [15]<br /><br>criteria 6 months after starting cannabis oil. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoint(s):<br /><br>a. to study objective response rate of cannabis oil in untreatable advanced HCC<br /><br>patients by assessing<br /><br>- RECIST[14] and mRECIST[15] criteria at 3 and 9 months after starting cannabis<br /><br>oil.<br /><br>- levels of the tumor markers alfa-fetoprotein (AFP) and<br /><br>des-gamma-carboxy-prothrombin (DCP) at 3, 6 and 9 months<br /><br><br /><br>b. to study quality of life at baseline, 3, 6 and 9 months using questionnaires<br /><br>EORTC-QLQ C30 and EORTC- QLQ HCC18<br /><br><br /><br>c. to compare cannabinoid receptor expression in the tumor (based on histology)<br /><br>between baseline and 6 months after treatment with cannabis oil.<br /><br><br /><br>d. to compare immune cell presence (including T-cells) in:<br /><br>- blood at time points baseline, 3, 6 and 9 months after treatment with<br /><br>cannabis oil. <br /><br>- tumor tissue at time points baseline and 6 months after treatment with<br /><br>cannabis oil<br /><br></p><br>