Orantinib In Combination With Transcatheter Arterial Chemoembolization In Patients With Unresectable Hepatocellular Carcinoma

Phase 3 Terminated 888 enrolled Taiho Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare the overall survival (OS) for Orantinib in combination with transcatheter arterial chemoembolization (TACE) versus placebo in combination with TACE in patients with unresectable hepatocellular carcinoma (HCC).

Timeline

Start: 2010-12
Primary completion: 2014-06
Completion: 2014-11

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo; p = 0.435; Hazard Ratio (HR) 1.090 (95% CI 0.878 to 1.352); Log Rank NCT01465464 ↗

paper INTERPRETATION: Orantinib combined with cTACE did not improve overall survival PMID 28988687 ↗

Publications

Kudo M, Cheng AL, Park JW, Park JH, Liang PC, Hidaka H, Izumi N, Heo J, Lee YJ, Sheen IS, Chiu CF, Arioka H, Morita S, Arai Y. Orantinib versus placebo combined with transcatheter arterial chemoembolisation in patients with unresectable hepatocellular carcinoma (ORIENTAL): a randomised, double-blind, placebo-controlled, multicentre, phase 3 study. Lancet Gastroenterol Hepatol. 2018 Jan;3(1):37-46. doi: 10.1016/S2468-1253(17)30290-X. Epub 2017 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Orantinib	Small molecule	200 mg	Oral