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Open Access Highly Accessed Correspondence

Eastern asian expert panel opinion: designing clinical trials of molecular targeted therapy for hepatocellular carcinoma

Winnie Yeo1*, Pei-Jer Chen2, Junji Furuse3, Kwang-Hyub Han4, Chiun Hsu2, Ho-Yeong Lim5, Hanlim Moon6, Shukui Qin7, Ee-Min Yeoh6 and Sheng-Long Ye8

Author Affiliations

1 Prince of Wales Hospital, Shatin, Hong Kong

2 National Taiwan University Hospital, Taipei, Taiwan

3 Kyorin University Hospital, Tokyo, Japan

4 Yonsei University, College of Medicine, Seoul, South Korea

5 Samsung Medical Centre, Seoul, South Korea

6 GlaxoSmithKline, Singapore

7 No. 81 Hospital of PLA, Nanjing, China

8 Zhongshan Hospital, Shanghai, China

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BMC Cancer 2010, 10:620  doi:10.1186/1471-2407-10-620

Published: 10 November 2010

Abstract

The largest burden of hepatocellular carcinoma (HCC) lies in Asia, secondary to hepatitis B virus (HBV) infection. Improved survival with sorafenib has fostered new research but many challenges remain in designing clinical trials. The disease, its management, and populations affected by it are heterogeneous worldwide and within Asia. An expert conference of Eastern Asian oncologists and hepatologists was convened to foster consensus in clinical trial design. The panel identified key areas that need to be addressed to facilitate clinical trials in Asia. Stratification by viral etiology is desirable within Asia and by region in global trials. Antiviral therapy should also be considered as a stratification factor and incorporated into HCC management in trials. The panel agreed that histological diagnosis is not required for trial entry and that Barcelona-Clinic Liver Cancer (BCLC) staging is acceptable for trials as long as portal hypertension can be better defined with standardized methodology. Consensus in treatment must be sought to allow multi-national trials and it must be recognized that first-line sorafenib is not largely feasible in Asia. Finally, Asian nations must be urged to participate in clinical trials, many of which are ongoing, to advance new treatment options in this challenging disease.