Condition category
Cancer
Date applied
28/10/2013
Date assigned
11/12/2013
Last edited
09/03/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Contact information

Type

Scientific

Primary contact

Prof David Adams

ORCID ID

Contact details

Centre of Liver Research
Institute of Biomedical Research
5th Floor
The University of Birmingham
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

2011-001690-62

ClinicalTrials.gov number

Protocol/serial number

VERSION 2 : RG_10-148

Study information

Scientific title

A randomised phase II clinical trial of conditioning cyclophosphamide and chemoembolisation with or without vaccination with dendritic cells pulsed with hepg2 lysate in vivo in patients with hepatocellular carcinoma (HCC)

Acronym

Study hypothesis

To determine whether activity due to the addition of dendritic cells (DC) vaccine to chemoembolisation and preconditioning cyclophosphamide warrants further investigation in a large randomised phase III clinical trial.

Ethics approval

UK National Ethics committee - NRES Committee West Midlands - Coventry and Warwickshire; Ref: 11/WM/0367

Study design

Phase II randomised trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Hepacellular Carcinoma

Intervention

Dendritic cell vaccine, Cyclophosphamide, TACE (standard treatment)

Intervention type

Drug

Phase

Phase II

Drug names

Cyclophosphamide

Primary outcome measures

Progression Free survival at every visit

Secondary outcome measures

1. Radiological response rate (RECIST criterion) measured at baseline, Day 60 and then every 3 months thereafter
2. Rate of change in the tumour marker serum alpha-fetoprotein (AFP) at every visit
3. Assessment of toxicity using National Cancer Institute – common terminology criteria for adverse events version 4.02 (NCI-CTCAE version 4) at every visit
4. Immune response rate at every visit
5. Overall survival

Overall trial start date

06/01/2014

Overall trial end date

06/01/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histological or cytological diagnosis or meet the American Association for the Study of Liver Diseases (AASLD) criteria for diagnosis of HCC and at least one unidimensional lesion measurable according to the Response Evaluation Criteria In Solid Tumors (RECIST) criteria by CT scan or MRI
2. Suitable for transcatheter arterial chemoembolization (TACE)
3. Aged >18 years and estimated life expectancy >6 months
4. Not a candidate for surgical resection or transplantation
5. No previous chemotherapy, radiotherapy, immunotherapy or other experimental treatment for HCC prior to entry into the trial
6. ECOG performance status <= 2
7. Adequate haematological function: Hb >9g/L, Absolute neutrophil count >1.5x109/L, platelet count >50x109/L
8. Bilirubin < 50 umol/L , AST or ALT < 5 x ULN
9. Adequate renal function: Cockroft and Gault estimation > 40ml/min
10. INR less than or equal to 1.5
11. ChildPugh score < 7
12. Women of childbearing potential should have a negative pregnancy test prior to trial entry
13. Women of childbearing potential and men who have partners of childbearing potential must be willing to practise effective contraception for the duration of the study and for three months after the completion of treatment.
14. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

70

Participant exclusion criteria

1. Extrahepatic metastasis
2. Prior embolisation, systemic or radiation therapy for HCC
3. Investigational therapy or major surgery within 4 weeks of trial entry
4. Any ablative therapy [radiofrequency ablation (RFA) or percutaneous ethanol injection (PEI)] for HCC [this should not exclude patients if target lesion(s) have not been treated and occurred >6 weeks prior trial entry]
5. Child Pugh score >7
6. Hepatic encephalopathy
7. Ascites refractory to diuretic therapy
8. Documented invasion of the main portal vein
9. Hypersensitivity to intravenous contrast agents
10. Active clinically serious infection >grade 2 NCI-CTC version 4.0 (appendix 7) within preceding two weeks
11. Pregnant or lactating women
12. History of second malignancy except those treated with curative intent more than three years previously without relapse and nonmelanotic skin cancer or cervical carcinoma in situ
13. Evidence of severe or uncontrolled systemic diseases, congestive cardiac failure >NYHA class 2, myocardial infarction (MI) within 6 months or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial
14. Psychiatric or other disorder likely to impact on informed consent
15. Known history of HIV
16. Patient is unable and/or unwilling to comply with treatment and trial instructions
17. Patients with active autoimmune disorder

Recruitment start date

06/01/2014

Recruitment end date

06/01/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Centre of Liver Research
Birmingham
B15 2TT
United Kingdom

Sponsor information

Organisation

University of Birmingham (UK)

Sponsor details

c/o Dr Sean Jennings
Research Support Group
Room 119
Aston Webb Building
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - EME grant

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes

09/03/2016: Link to Cancer Help UK lay summary added.