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

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

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma; Cannabis
• Intervention / Treatment: Drug: Medical Cannabis

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: M W Nijkamp, MD PhD; Phone Number: +31625649985; Email: m.w.nijkamp@umcg.nl
• Study Contact Backup: Name: DJ A de Groot, MD PhD

Study Locations

• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Recruiting
    • University Medical Center Groningen
    • Contact: Maarten W Nijkamp, MD PhD; Phone Number: +31625649985; Email: m.w.nijkamp@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cannabis oil; Treatment with cannabis oil	Drug: Medical Cannabis; Medical cannabis oil three times daily; Other Names: Cannabis oil containing 10% delta-9-tetrahydrocannabinol (THC) and 5% cannabidiol (CBD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor size	Tumor size based on RECIST and mRECIST criteria	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor size	Tumor size based on RECIST and mRECIST criteria	3 months
Tumor size	Tumor size based on RECIST and mRECIST criteria	6 months
Tumor markers	Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)	3 months
Tumor markers	Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)	6 months
Tumor markers	Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT)	9 months
Quality of Life questionnaires	EORTC-QLQ30 and -HCC18	3 months
Quality of Life questionnaires	EORTC-QLQ30 and -HCC18	6 months
Quality of Life questionnaires	EORTC-QLQ30 and -HCC18	9 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: M W Nijkamp, MD PhD, University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Estimated): April 15, 2027
• Study Completion (Estimated): April 15, 2027

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: July 23, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; Substance-Related Disorders; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Marijuana Abuse; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Psychotropic Drugs; Anticonvulsants; Hallucinogens; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Dronabinol; Cannabidiol
• Other Study ID Numbers: 201800881

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No