Eastern Asian expert panel opinion: designing clinical trials of molecular targeted therapy for hepatocellular carcinoma.
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.
Prince of Wales Hospital, Shatin, Hong Kong. winnie@clo.cuhk.edu.hk
Winnie
W
Yeo
Pei-Jer
PJ
Chen
Junji
J
Furuse
Kwang-Hyub
KH
Han
Chiun
C
Hsu
Ho-Yeong
HY
Lim
Hanlim
H
Moon
Shukui
S
Qin
Ee-Min
EM
Yeoh
Sheng-Long
SL
Ye
D001208:Asia; D006528:Carcinoma, Hepatocellular / Q000628:therapy*; D002986:Clinical Trials as Topic; D006801:Humans; D008113:Liver Neoplasms / Q000628:therapy*; D008495:Medical Oncology / Q000379:methods* / Q000639:trends; D058990:Molecular Targeted Therapy / Q000379:methods*; D009367:Neoplasm Staging / Q000379:methods; D012107:Research Design