| Title: |
Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial |
| Authors: |
Meyer T; Fox R; Ma YT; Ross PJ; James MW; Sturgess R; Stubbs C; Stocken DD; Wall L; Watkinson A; Hacking N; Evans TRJ; Collins P; Hubner RA; Cunningham D; Primrose JN; Johnson PJ; Palmer DH |
| Source: |
The Lancet Gastroenterology and Hepatology, August 2017 |
| Publisher Information: |
Elsevier Ltd |
| Publication Year: |
2017 |
| Collection: |
Newcastle University Library ePrints Service |
| Description: |
© 2017 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license Background Transarterial chemoembolisation (TACE) is the standard of care for patients with intermediate stage hepatocellular carcinoma, while the multikinase inhibitor sorafenib improves survival in patients with advanced disease. We aimed to determine whether TACE with sorafenib improves progression-free survival versus TACE with placebo. Methods We did a multicentre, randomised, placebo-controlled, phase 3 trial (TACE 2) in 20 hospitals in the UK for patients with unresectable, liver-confined hepatocellular carcinoma. Patients were eligible if they were at least aged 18 years, had Eastern Cooperative Oncology Group performance status of 1 or less, and had Child-Pugh A liver disease. Patients were randomised 1:1 by computerised minimisation algorithm to continuous oral sorafenib (400 mg twice-daily) or matching placebo combined with TACE using drug-eluting beads (DEB-TACE), which was given via the hepatic artery 2–5 weeks after randomisation and according to radiological response and patient tolerance thereafter. Patients were stratified according to randomising centre and serum α-fetoprotein concentration ( |
| Document Type: |
article in journal/newspaper |
| File Description: |
application/pdf |
| Language: |
unknown |
| Relation: |
https://eprints.ncl.ac.uk/239923; https://eprints.ncl.ac.uk/fulltext.aspx?url=239923/B98F3320-F8A0-4513-BB8F-6554B8BD5A66.pdf&pub_id=239923 |
| Availability: |
https://eprints.ncl.ac.uk/239923 |
| Rights: |
https://creativecommons.org/licenses/by-nc-nd/4.0/ |
| Accession Number: |
edsbas.C73CD388 |
| Database: |
BASE |