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

Phase 2

Recruiting

• Conditions: Cannabis; Hepatocellular Carcinoma
• Interventions: Drug: Medical Cannabis

• Registration Number: NCT06518434
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-15
• Study First Submitted: 2021-09-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Study First Posted: 2024-07-24
• Last Update Posted: 2024-07-24
• Primary Completion: 2027-04-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• 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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cannabis oil	Medical Cannabis	Treatment with cannabis oil

Primary Outcome Measures

Name	Time	Method
Tumor size	9 months	Tumor size based on RECIST and mRECIST criteria

Secondary Outcome Measures

Name	Time	Method
Tumor markers	9 months	Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)
Tumor size	6 months	Tumor size based on RECIST and mRECIST criteria
Quality of Life questionnaires	9 months	EORTC-QLQ30 and -HCC18

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands