Hepatocellular CarcinomaPhase 2CanHepNCT06518434
A Pilot Study on the Effect of Cannabis Oil in Untreatable Liver Cancer Patients
A Phase 2 study testing Medical Cannabis in people with Hepatocellular Carcinoma and Cannabis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Cannabis
- What is being tested?
- Medical Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Apr 2021to 15 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
DJ A de Groot, MD PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Maarten W Nijkamp, MD PhD, +31625649985, m.w.nijkamp@umcg.nl
About this study
Official title: A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
- Conditions
- Hepatocellular Carcinoma, Cannabis
- Being tested
- Medical Cannabis
- Medical subject headings
- Carcinoma, Hepatocellular, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical CannabisDrug
Also called Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)
Medical cannabis oil three times daily
| Study group | Role | What they receive |
|---|---|---|
| Cannabis oil | Experimental | Treatment with cannabis oil Receives: Drug: Medical Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
Tumor size based on RECIST and mRECIST criteria
Measured: 9 months
Secondary outcomes (8)
Tumor size
Tumor size based on RECIST and mRECIST criteria
Measured: 3 months
Tumor size
Tumor size based on RECIST and mRECIST criteria
Measured: 6 months
Tumor markers
Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)
Measured: 3 months
Tumor markers
Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)
Measured: 6 months
Tumor markers
Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)
Measured: 9 months
Quality of Life questionnaires
EORTC-QLQ30 and -HCC18
Measured: 3 months
Quality of Life questionnaires
EORTC-QLQ30 and -HCC18
Measured: 6 months
Quality of Life questionnaires
EORTC-QLQ30 and -HCC18
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start15 Apr 2021
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maarten Nijkamp, University Medical Center Groningen
- Investigators
- M W Nijkamp, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518434
- Sponsor's protocol ID
- 201800881
- Acronym
- CanHep
- Status last verified
- Jul 2024
- First submitted
- 28 Sep 2021
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06518434
- Acronym / sponsor ID
- CanHep / 201800881
- Conditions
- Hepatocellular Carcinoma, Cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabis oil | Experimental | Drug: Medical CannabisTreatment with cannabis oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical CannabisAlso: Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)Medical cannabis oil three times daily | Drug | Cannabis oil |
Primary outcome
Tumor size
Time frame: 9 months
Tumor size based on RECIST and mRECIST criteria
8 secondary outcomes
Tumor size
Time frame: 3 months
Tumor size
Time frame: 6 months
Tumor markers
Time frame: 3 months
Tumor markers
Time frame: 6 months
Tumor markers
Time frame: 9 months
Quality of Life questionnaires
Time frame: 3 months
Quality of Life questionnaires
Time frame: 6 months
Quality of Life questionnaires
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DJ A de Groot, MD PhD contact
M W Nijkamp, MD PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medical Cannabis in people with Hepatocellular Carcinoma and Cannabis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact M W Nijkamp, MD PhD (+31625649985, m.w.nijkamp@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor size (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.