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The DOI matches its Crossref record; 45 of the 45 references it cites were found in a registry or an index.

Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial

Open access
Lencioni, Riccardo, Llovet, Josep M., Han, Guohong, Tak, Won Young, Yang, Jiamei, Guglielmi, Alfredo, Paik, Seung Woon, Reig, Maria, Kim, Do Young, Chau, Gar-Yang, Luca, Angelo, del Arbol, Luis Ruiz, Leberre, Marie-Aude, Niu, Woody, Nicholson, Kate, Meinhardt, Gerold, Bruix, Jordi·2016·Journal of Hepatology
DOI 10.1016/j.jhep.2016.01.012
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Abstract

BACKGROUND & AIMS Transarterial chemoembolization with doxorubicin-eluting beads (DC Bead®; DEB-TACE) is effective in patients with Barcelona clinic liver cancer stage B hepatocellular carcinoma (HCC). The multikinase inhibitor sorafenib enhances overall survival (OS) and time-to-tumor progression (TTP) in patients with advanced HCC. This exploratory phase II trial tested the efficacy and safety of DEB-TACE plus sorafenib in patients with intermediate stage HCC. METHODS Patients with intermediate stage multinodular HCC without macrovascular invasion (MVI) or extrahepatic spread (EHS) were randomized 1:1 to DEB-TACE (150 mg doxorubicin) plus sorafenib 400 mg twice daily or placebo. The primary endpoint was TTP by blinded central review. Secondary endpoints included time to MVI/EHS, OS, overall response rate (ORR) using modified response evaluation criteria in solid tumors, disease control rate (DCR), time to unTACEable progression (TTUP), and safety. RESULTS Of 307 patients randomized, 154 received sorafenib and 153 received placebo. Median TTP for subjects receiving sorafenib plus DEB-TACE or placebo plus DEB-TACE was similar (169 vs. 166 days, respectively; hazard ratio (HR) 0.797, p=0.072). Median time to MVI/EHS (HR 0.621, p=0.076) and OS (HR 0.898, p=0.29) had not been reached. The ORRs for patients in the sorafenib and placebo groups with post-baseline scans were 55.9% and 41.3%, respectively, and the DCRs were 89.2% and 76.1%, respectively. TTUP was lower with sorafenib than with placebo (HR 1.586; 95% confidence intervals, 1.200-2.096; median 95 vs. 224 days). No unexpected adverse events related to sorafenib were observed. CONCLUSION Sorafenib plus DEB-TACE was technically feasible, but the combination did not improve TTP in a clinically meaningful manner compared with DEB-TACE alone.

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Metadata

Authors
Lencioni, R., Llovet, J. M., Han, G., Tak, W. Y., Yang, J., Guglielmi, A., Paik, S. W., Reig, M., Kim, D. Y., Chau, G.-Y., Luca, A., del Arbol, L. R., Leberre, M.-A., Niu, W., Nicholson, K., Meinhardt, G., & Bruix, J.
Venue
Journal of Hepatology
Publisher
Elsevier BV
Published
2016-05
Volume
64
Issue
5
Pages
1090-1098
ISSN
0168-8278 (ISSN-L)
DOI
10.1016/j.jhep.2016.01.012
OpenAlex
W2286222994
Cited by
694
References
45
FWCI
47.97
Type
journal article
Language
en
Open access
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CoChat. (2026). Citation check: Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. https://app.cochat.ai/papers/10.1016/j.jhep.2016.01.012
The paper
Lencioni, R., Llovet, J. M., Han, G., Tak, W. Y., Yang, J., Guglielmi, A., Paik, S. W., Reig, M., Kim, D. Y., Chau, G.-Y., Luca, A., del Arbol, L. R., Leberre, M.-A., Niu, W., Nicholson, K., Meinhardt, G., & Bruix, J. (2016). Sorafenib or placebo plus TACE with doxorubicin-eluting beads for intermediate stage HCC: The SPACE trial. Journal of Hepatology. https://doi.org/10.1016/j.jhep.2016.01.012

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.