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Recruiting

NCT Number: NCT06518434

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location status: Recruiting

Location contact

Maarten W Nijkamp, MD PhD

CONTACT

[email protected]

+31625649985

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical Cannabis

Drug

Medical cannabis oil three times daily

Other names: Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)

Primary outcomes

  1. Tumor size

    Time frame: 9 months

    Tumor size based on RECIST and mRECIST criteria

Secondary outcomes

  1. Tumor size

    Time frame: 3 months

    Tumor size based on RECIST and mRECIST criteria

  2. Tumor size

    Time frame: 6 months

    Tumor size based on RECIST and mRECIST criteria

  3. Tumor markers

    Time frame: 3 months

    Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)

  4. Tumor markers

    Time frame: 6 months

    Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)

  5. Tumor markers

    Time frame: 9 months

    Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)

  6. Quality of Life questionnaires

    Time frame: 3 months

    EORTC-QLQ30 and -HCC18

  7. Quality of Life questionnaires

    Time frame: 6 months

    EORTC-QLQ30 and -HCC18

  8. Quality of Life questionnaires

    Time frame: 9 months

    EORTC-QLQ30 and -HCC18

Study contacts

Contact information is provided by the study sponsor or research team.

DJ A de Groot, MD PhD

CONTACT

M W Nijkamp, MD PhD

CONTACT

[email protected]

+31625649985

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Official study title

A Phase 2a Study on the Anti-tumoral Effect of Cannabis Oil (THC 10% / CBD 5%) in Patients With Advanced Untreatable Hepatocellular Carcinoma

Acronym: CanHep

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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