Clinical trial · Interventional
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
NCT06518434CI-TRIAL-00079096CanHeprecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cannabis | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Medical Cannabis | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cannabis oil
- description
- Treatment with cannabis oil
- interventionNames
- Drug: Medical Cannabis
Primary outcomes (1)
- measure
- Tumor size
- timeFrame
- 9 months
- description
- Tumor size based on RECIST and mRECIST criteria
Secondary outcomes (8)
- measure
- Tumor size
- timeFrame
- 3 months
- description
- Tumor size based on RECIST and mRECIST criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.