Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00079027
Protocol/serial number
HE3001
Study information
Scientific title
Acronym
HEP-1
Study hypothesis
To test the hypothesis that patients with advanced, unresectable HCC treated with CEM will have an improved survival compared to those treated with single agent Doxorubicin.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://www.hep1.bham.ac.uk/HEP1-PatientGeneralInfo-v1.5.pdf
Condition
Unresectable, advanced hepatocellular carcinoma
Intervention
Control Arm: Single agent doxorubicin, max dose 60 mg/m^2 IV day 1, repeated once every 3 weeks for a max of 6 cycles
Treatment Arm: Chemoembolisation (CEM) using doxorubicin, repeated every 8 weeks for a max of 3 procedures
Intervention type
Drug
Phase
Not Applicable
Drug names
Doxorubicin
Primary outcome measures
Survival
Secondary outcome measures
1. Overall Response (determined by RECIST criteria)
2. Time to progression (determined by RECIST criteria)
3. Toxicity
4. QoL
5. Health economics
6. Proteomics
7. Immunological
Overall trial start date
01/10/2005
Overall trial end date
01/10/2010
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
1. Histological or cytological diagnosis or The European Association for the Study of the Liver (EASL) criteria met for unresectable HCC
2. No prior systemic or regional chemotherapy
3. Aged greater than or equal to 18 years (or greater than or equal to 16 years in Scotland)
4. Laboratory parameters:
4.1. Haemoglobin (Hb) greater than or equal to 8.5 g/dl
4.2. Platelets greater than or equal to 100,000/mm^3
4.3. Absolute neutrophil count (ANC) greater than or equal to 1500/mm^3
4.4. International normalised ratio (INR) less than 1.5
4.5. Bilirubin less than or equal to 50 µm/L
4.6. Transaminases less than 2.5 x upper limit of normal (ULN)
4.7. Serum creatinine less than 2 x ULN
5. Eastern Coooperative Oncology Group (ECOG) performance status less than or equal to 2
6. Modified Pugh's Child B grade or better
7. Not of childbearing potential or using an approved method of contraception
8. Written informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
280
Participant exclusion criteria
1. New York Heart Association (NYHA) Class III/IV cardiac disease
2. Left ventricular ejection fraction (LVEF) of less than 50% or acute anginal symptoms
3. Thrombosis of main portal vein
4. Main portal vein occlusion/involvement
5. Patients whom in the opinion of the investigator have 'clinically significant ascites'
6. History of second malignancy within 5 years prior to trial entry, excepting cervical carcinoma-in-situ or non-melanotic skin cancer
7. Previous chemotherapy, radiotherapy, biological or hormone therapy given for hepatocellular carcinoma
8. Any ablative therapy for hepatocellular carcinoma within the last 6 weeks. Radiological evidence of progression is required if assessing a previously ablated site as the only site of disease.
9. Use of other investigational agent during the study or within 4 weeks of planned study entry
10. Major surgery within 7 days or laparoscopy within 3 days of trial entry
11. A serious co-existing medical condition including a potential serious infection or significant peripheral vascular disease
12. Psychological, familial, sociological or geographical factors considered likely to prevent compliance with the protocol
13. Presence of extrahepatic tumour of any kind
Recruitment start date
01/10/2005
Recruitment end date
01/10/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Edinburgh
Edinburgh
EH16 4SA
United Kingdom
Sponsor information
Organisation
The University of Birmingham and University of Edinburgh (UK)
Sponsor details
Research & Enterprise Services
Muirhead Tower
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (CRUK) (UK) (ref: C9041/A4578)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary