Small patient study to explore the anticancer effect of cannabis oil in untreatable patients with liver cancer

Phase 1

• Conditions: The anti-tumoral effect of cannabis oil will be investigated in patients with untreatable HCC; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004505-34-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Age =>18 yrs
- Histologically proven hepatocellular carcinoma
- MDT-advised best supportive care for untreatable advanced HCC or patients unable to undergo or denying treatment for advanced HCC.
- Minimal life expectancy of 3 months
- Willing and able to attend follow-up examinations
- Willing to stop driving, if applicable
- Signed informed consent
- Language: Dutch or English

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

-Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
-Contra-indications for medicinal cannabis oil:
oPsychotic disorders
oCardiac arrhythmias
oAngina pectoris
oPregnancy or lactation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients based on mRECIST and RECIST criteria;Secondary Objective: to study quality of life using questionnaire EORTC-QLQ C30 en -HCC18;Primary end point(s): to study the anti-tumor effect of cannabis oil (THC10% / CBD5%) in untreatable HCC patients by assessing tumor size at 6 months after starting treatment based on RECIST and mRECIST criteria ;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): a. to study the anti-tumor effect of cannabis oil in untreatable HCC patients by assessing <br>- tumor size at 3 and 9 months after starting treatment based on RECIST en mRECIST criteria<br>- Tumor markers Alfa-foetoprotein (AFP) and des-gamma-carboxy-protrombine (DGCPT) at 3, 6 and 9 months<br><br>b. to study quality of life at 3, 6 and 9 months using questionnaire EORTC-QLQ C30;Timepoint(s) of evaluation of this end point: 3 ,(6) and 9 months