PRIME-HCC
Research type
Research Study
Full title
PRIME-HCC: Preliminary assessment of safety and bioactivity of the Ipilimumab and Nivolumab combination prior to liver resection (LR) in hepatocellular carcinoma (HCC).
IRAS ID
244863
Contact name
David Pinato
Contact email
Eudract number
2018-000987-27
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Hepatocellular carcinoma (HCC) is the sixth commonest, and third most lethal, solid malignancy on a global scale. In spite of major advancements in the diagnosis of HCC, only 30% of newly diagnosed patients are presently eligible for treatments with curative intent. One such treatment is liver resection (LR), which is clinically recommended in patients presenting with liver-confined HCC, and with preserved liver function and performance status. However, even in the context of LR, 5-year survival rates for early-stage HCC range between 17-53%, and recurrence rates can be as high as 70%. There is a need to integrate LR with systemic anti-cancer therapies which can reduce the risk of relapse, and increase the chances of cure in patients with early-stage HCC. Furthermore, because less than 30% of patients with HCC can be offered LR, there is a need for systemic anti-cancer therapies as a pre-operative strategy to attempt disease down-staging in order to expand the proportion of patients who might benefit from curative surgery. The PRIME-HCC trial will assess the effects of combination treatment with Nivolumab and Ipilimumab pre-operatively in HCC patients for whom LR is planned. The trial will be conducted at a small number of NHS hospitals in the UK. Participants will receive two doses of Nivolumab and a single dose of Ipilimumab in the weeks before their planned LR.
REC name
London - South East Research Ethics Committee
REC reference
18/LO/1709
Date of REC Opinion
24 Oct 2018
REC opinion
Favourable Opinion