Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
20
Countries
1
Sites
1
Patients with untreatable hepatocellulare carcinoma
to study the anti-tumoral effect of cannabis oil (THC10% / CBD5%) in untreatable advanced HCC patients.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Oct 2024 → ongoing
- Decision date (initial)
- 2024-10-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514049-13-02
- EudraCT number
- 2018-004505-34
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
to study the anti-tumoral effect of cannabis oil (THC10% / CBD5%) in untreatable advanced HCC patients.
Conditions and MedDRA coding
Patients with untreatable hepatocellulare carcinoma
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-514049-13-00 | A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10% / CBD 5%) in patients with untreatable advanced hepatocellular carcinoma - the CanHep study | Universitair Medisch Centrum Groningen |
| 2024-514049-13-01 | A phase 2a study on the anti-tumoral effect of cannabis oil (THC 10% / CBD 5%) in patients with untreatable advanced hepatocellular carcinoma - the CanHep study | Universitair Medisch Centrum Groningen |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- 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 6
- 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: 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB26600 · Substance
- Active substance
- Cannabidiol
- Pharmaceutical form
- OROMUCOSAL SPRAY, SOLUTION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 37.5 mg milligram(s)
- Max total dose
- 202.5 g gram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- During this trial, cannabis oil containing 10% dronabinol and 5% cannabidiol is manufactured and used by the trial participants.
SUB06407MIG · Substance
- Active substance
- Dronabinol
- Pharmaceutical form
- OROMUCOSAL SPRAY, SOLUTION
- Route of administration
- SUBLINGUAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 405 g gram(s)
- Max treatment duration
- 9 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- During this trial, cannabis oil containing 10% dronabinol and 5% cannabidiol is manufactured and used by the trial participants.
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- M.W.Nijkamp
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- M.W.Nijkamp
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 20 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Universitair Medisch Centrum Groningen
Surgery, Hanzeplein 1, 9713 GZ, Groningen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2024-10-29 | 2024-10-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 3 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol 2024-514049-13-02_redacted | 2.1 |
| Recruitment arrangements (for publication) | Blanc document | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF all participants | 2.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-03 | Netherlands | Acceptable with conditions 2024-10-29
|
2024-10-29 |