NCT06518434

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2 hepatocellular-carcinoma

Timeline
8mo left

Started Apr 2021

Longer than P75 for phase_2 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 2021Apr 2027

Study Start

First participant enrolled

April 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2027

Last Updated

July 24, 2024

Status Verified

July 1, 2024

Enrollment Period

6 years

First QC Date

September 28, 2021

Last Update Submit

July 23, 2024

Conditions

Hepatocellular CarcinomaCannabis

Outcome Measures

Primary Outcomes (1)

  • Tumor size

    Tumor size based on RECIST and mRECIST criteria

    9 months

Secondary Outcomes (8)

  • Tumor size

    3 months

  • Tumor size

    6 months

  • Tumor markers

    3 months

  • Tumor markers

    6 months

  • Tumor markers

    9 months

  • +3 more secondary outcomes

Study Arms (1)

Cannabis oil

EXPERIMENTAL

Treatment with cannabis oil

Drug: Medical Cannabis

Interventions

Medical CannabisDRUG

Medical cannabis oil three times daily

Also known as: Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)
Cannabis oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularMarijuana Abuse

Interventions

Medical MarijuanaDronabinolCannabidiol

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsCannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • M W Nijkamp, MD PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M W Nijkamp, MD PhD

CONTACT

+31625649985m.w.nijkamp@umcg.nl

DJ A de Groot, MD PhD

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2021

First Posted

July 24, 2024

Study Start

April 15, 2021

Primary Completion (Estimated)

April 15, 2027

Study Completion (Estimated)

April 15, 2027

Last Updated

July 24, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)