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TACE-3

A two-arm multi-stage (TAMS) seamless phase II/III randomised trial of nivolumab in combination with TACE for patients with intermediate stage HCC

TACE-3

A two-arm multi-stage (TAMS) seamless phase II/III randomised trial of nivolumab in combination with TACE for patients with intermediate stage HCC
Funding Bristol Myers Squibb (BMS)
Portfolio Cancer
Interventions Medicine
Randomised Yes
Status Funding awarded/in set-up
Start Date 01-Jan-0001

This study will look at adding a new treatment to the current standard of care in patients with Liver Cancer. We will recruit patients who have had their liver cancer confirmed by having a biopsy and who undergo tests to check they are safe to include on the study.
Liver cancer is usually treated by a therapy called Transarterial Chemoembolization (TACE) with DC Bead loaded with doxorubicin. This therapy puts a large dose of chemotherapy (chemo) drugs right into the tumour. This puts more of the drugs right on the cancer cells and lessens their side effect on other tissues. Patients are usually treated with TACE therapy until the tumour shows signs of growing/spreading.
There is evidence to suggest that giving an Immunotherapy drug at the same time as TACE treatment may help increase the time patient’s cancer remains stable and does not grow/spread. We will be adding a new drug called nivolumab which is given into a vein via a drip every 4 weeks, alongside the TACE therapy. This drug stimulates the immune system and when it works, sometimes does so for a long period of time.
In this study we will treat half the patients with the TACE therapy alone and the other half with TACE and the drug nivolumab. All patients will be treated until their scans show that there their cancer is no longer responding to the therapy or a maximum of 24 months.
We will also look at the side effects in the different treatment groups and the quality of life of the patients being treated.

Publications

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