| 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 |
| Publisher Information: |
Elsevier |
| Publication Year: |
2017 |
| Collection: |
White Rose Research Online (Universities of Leeds, Sheffield & York) |
| Description: |
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: |
text |
| Language: |
English |
| ISSN: |
2468-1253 |
| Relation: |
https://eprints.whiterose.ac.uk/id/eprint/164660/1/2017%20Lancet%20Gastroent%20Hepatol%20TACE-2.pdf; Meyer, T, Fox, R, Ma, YT et al. (15 more authors) (2017) Sorafenib in combination with transarterial chemoembolisation in patients with unresectable hepatocellular carcinoma (TACE 2): a randomised placebo-controlled, double-blind, phase 3 trial. The Lancet Gastroenterology & Hepatology, 2 (8). pp. 565-575. ISSN: 2468-1253 |
| Availability: |
https://eprints.whiterose.ac.uk/id/eprint/164660/ |
| Rights: |
cc_by_nc_nd_4 |
| Accession Number: |
edsbas.76972B2F |
| Database: |
BASE |