Eisai Clinical Trials

A Multicenter, Randomized, 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

E7080-G000-304

Study Overview

E7080
lenvatinib
NCT01761266, JapicCTI-132113, jRCT2080222067, 2012-002992-33
Mar 2013 - Mar 2021
Hepatocellular Carcinoma (HCC)
1. Overall Survival (OS) [Time Frame: From date of randomization until date of death from any cause (approximately up to 3.8 years)]

  • Males and females 18 Years and older (Adult, Older Adult)

  • Completed

  • 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

Results

CSR Synopsis

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Lay Summary

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Publication reference citation

Kudo M, Finn RS, Qin S, Han KH, Ikeda K, Cheng AL, Vogel A, Tovoli F, Ueshima K, Aikata H, Lopez CL, Pracht M, Meng Z, Daniele B, Park JW, Palmer D, Tamai T, Saito K, Dutcus CE, Lencioni R. Overall survival and objective response in advanced unresectable hepatocellular carcinoma: A subanalysis of the REFLECT study. J Hepatol. 2023 Jan;78(1):133-141. doi: 10.1016/j.jhep.2022.09.006. Epub 2022 Sep 20.

Huynh J, Cho MT, Kim EJ, Ren M, Ramji Z, Vogel A. Lenvatinib in patients with unresectable hepatocellular carcinoma who progressed to Child-Pugh B liver function. Ther Adv Med Oncol. 2022 Aug 24;14:17588359221116608. doi: 10.1177/17588359221116608. eCollection 2022.

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.

CSDR Sharing is not available for this study.

CSDR Availability
Clinical Trial Data

Redacted documents may be available upon request for this study.

Document type Availability
Protocol
SAP
Sample CRF
Full CSR