A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients (CanHep)

University Medical Center Groningen (UMCG)

Status and phase

Enrolling

Phase 2

Conditions

Cannabis

Hepatocellular Carcinoma

Treatments

Drug: Medical Cannabis

Study type

Interventional

Funder types

Other

Identifiers

201800881

Details and patient eligibility

About

to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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