CANNABIDIOL for Advanced hepatocellular carcinoma

Inclusion criteria

• {"criterion_text":"- Age =>18 yrs\n- Language: Dutch or English\n- Histologically proven hepatocellular carcinoma\n- Non-cirrhosis or Child Pugh A cirrhosis\n- Hepatic encephalopathy grade 0 or 1\n- Multidisciplinary treatment (MDT)-advised best supportive care for untreatable advanced HCC or patients unable to undergo or declining treatment for advanced HCC\n- Minimal life expectancy of 3 months\n- Willing and able to attend follow-up examinations\n- Willing to stop active traffic participation or controlling machinery during the study period if applicable\n- Signed informed consent"}

Exclusion criteria

• {"criterion_text":"- Child Pugh B or C cirrhosis\n- Hepatic encephalopathy grade 2 or more\n- Previous systemic treatment for HCC\n- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial\n- Use of medicinal cannabis for other purposes\n- 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"}

Primary endpoints

• {"endpoint_text":"- To study objective response rate (ORR) of cannabis oil (THC10% / CBD5%) in untreatable advanced HCC patients by assessing RECIST31 and mRECIST32 criteria on imaging at 9 months after starting cannabis oil.","definition_or_measurement_approach":"Objective response rate (ORR) assessed by RECIST and mRECIST criteria on imaging at 9 months after starting treatment."}

Netherlands

Earliest CTIS Part Ii Submission Date

22-10-2024

Latest Decision Or Authorization Date

29-10-2024

Processing Time Days

7

Number Of Sites

1

Number Of Participants

20

Primary sponsor

Full Name

Universitair Medisch Centrum Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands