TACE-3
Research type
Research Study
Full title
TACE-3: A two-arm multi-stage (TAMS) seamless phase II/III randomised trial of nivolumab in combination with TACE/TAE for patients with intermediate stage HCC
IRAS ID
241427
Contact name
Daniel Palmer
Contact email
Sponsor organisation
The Clatterbridge Cancer Centre NHS Foundation Trust
Eudract number
2018-000004-42
ISRCTN Number
ISRCTN12053408
Duration of Study in the UK
7 years, 0 months, 0 days
Research summary
This study is looking to see if adding the drug nivolumab to the current standard treatment will be better for treating patients with liver cancer.
The current treatment TAE (Transcatheter Arterial Embolisation) TACE (Transcatheter Arterial Chemoembolisation) blocks blood supply to the tumour and (where applicable) puts a large dose of chemotherapy drugs directly into the tumour. Putting the drug directly into the tumour gives less side effects and less damage to other tissues nearby. Current evidence suggests that adding an immunotherapy drug like Nivolumab at the same time as TACE may help increase the time taken until the tumour begins to grow/spread.
The study is looking at patients who have liver cancer (Hepatocellular carcinoma (HCC)) which is classified as intermediate. Patients will need to undergo some tests and a biopsy of their Liver to confirm it is safe and they are suitable to be included in the trial. The study will be conducted across NHS hospitals in the UK and in hospitals in France.
In this study we will treat half the patients with TACE on its own and the other half with TACE and the new drug nivolumab. Patients will have regular scans to look at their cancer and will be treated until the cancer has grown. Nivolumab will be given once before a patient’s first TACE therapy and then every 4 weeks alongside any further TACE therapy given. Patients will be on study treatment for a maximum of 2 years.
We will look at how long it takes for patient’s cancer to grow, how long patients survive, the side effects patients suffer and also Quality of Life.
The study is split into two parts. If the first part (phase II) of the study shows that the drug maybe working to control patient’s cancers, we will expand the study to recruit more patients in part two (phase III).
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0699
Date of REC Opinion
16 Jan 2019
REC opinion
Further Information Favourable Opinion