Eisai Clinical Trials

A Multicenter, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma


Study Overview

NCT01761266, EU CTR 2012-002992-33
Mar 2013 - Nov 2016
Hepatocellular Carcinoma (HCC)
Overall survival (OS)

  • Males and females (age 18 years and over)

  • Active, not recruiting

  • Phase 3

  • Australia, Belgium, Canada, China, France, Germany, Hong Kong, Israel, Italy, Japan, Korea, Republic of, Malaysia, Philippines, Poland, Russian Federation, Singapore, Spain, Taiwan, Thailand, United Kingdom, United States See more


CSR Synopsis

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Lay Summary

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Publication reference citation

Kudo M et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial. Lancet. 2018 Mar 24;391(10126):1163-1173.
DOI: 10.1016/S0140-6736(18)30207-1

Yamashita T, et al. REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset. J Gastroenterol. 2019 Nov 12. [Epub ahead of print]
DOI: 10.1007/s00535-019-01642-1

Evans TRJ, et al. Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma. Br J Cancer. 2019 Jul;121(3):218-221. Epub 2019 Jun 28. Erratum in: Br J Cancer. 2019 Jul 30.
DOI: 10.1038/s41416-019-0506-6

Data Sharing

ClinicalStudyDataRequest.com (CSDR) is a multi sponsor site through which qualified researchers who wish to access clinical trial data and associated information in order to conduct further research can submit their research proposal or enquiry.

Redacted documents are available upon request for this study.

Document type Availability
Sample CRF
Full CSR