IMMUNOTACE
Research type
Research Study
Full 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
IRAS ID
60187
Contact name
David Adams
Contact email
Sponsor organisation
University of Birmingham
Eudract number
2011-001690-62
ISRCTN Number
.
Clinicaltrials.gov Identifier
.
Research summary
Primary liver cancer or hepatocellular carcinoma (HCC) is the third most common cause of cancer-related death worldwide and it is becoming a major health burden in the UK. Unfortunately, prognosis remains extremely poor for the majority of patients with HCC and the current 5-year survival for all stages combined is less than 5%. At present surgery is the only potentially curative treatment for HCC. However, this is only limited to a small proportion of patients with early disease. Patients who are unsuitable for surgery may derive palliative benefit from transarterial chemoembolisation (TACE). This involves direct injection of a chemotherapy agent, into the blood vessels supplying the cancer, followed by blockage of these vessels to starve the cancer of blood flow. Evidence has shown that TACE may have the added effect of activating the immune system to destroy cancer cells and we propose to amplify this response further, by using an anti-cancer vaccine. Dendritic cells (DC) are special white blood cells that are highly effective at stimulating the immune system. They can be derived from patients' blood, loaded with proteins from cancer cells and re-infused to activate the anti-cancer immune responses. It is believed that cancer cells can directly suppress the immune system and lead to cancer progression. This is what is thought to be the reason for resistance to anti cancer treatments. An infusion of a low dose chemotherapeutic agent called cyclophosphamide has been shown to selectively inhibit the suppressive element of cancer cells, leading to enhancement of the anti-cancer immune response. In this study we will combine DC vaccination with cyclophosphamide and TACE as a treatment for patients with locally advanced HCC. We hypothesise that such combination treatment will generate a long lasting anti-cancer immune response, leading to an improvement in patient??s outcomes.
REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
11/WM/0367
Date of REC Opinion
29 Nov 2011
REC opinion
Favourable Opinion