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Table 1 Ongoing Phase II/III Trials in Advanced HCC

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

Study Name
Clinicaltrials.gov Identifier
Phase Intervention Setting Location
Advanced Disease
Targeted Agents With Cytotoxic Therapy
NCT00832637 II Erlotinib + gemcitabine + oxaliplatin Prior systemic therapy allowed US
HOG GI06-101
NCT00532441
II Erlotinib + docetaxel Third-line or less US
NCT00384800 II Thalidomide + tegafur/uracil No prior chemotherapy Taiwan
NCT00519688 II Thalidomide + tegafur/uracil No prior chemotherapy Taiwan
NCT00862082 I/II Sorafenib + PR104
Sorafenib
First-line US, Asia
Anti-VEGF Agents as Monotherapy
BRISK
NCT00858871
III Brivanib + placebo
Sorafenib + placebo
First-line International
NCT00825955 III Brivanib + placebo
BSC + placebo
Sorafenib failure International
NCT00699374 III Sunitinib
Sorafenib
First-line International
NCT00247676 II Sunitinib First-line France, Korea, Taiwan
Other Targeted Agents as Monotherapy
NCT00225290 III Thalidomide
Placebo
Any line
Poor liver reserve
Taiwan
NCT00033462 II Erlotinib First- or second-line US
NCT00077441 II Bortezomib First-line US, Australia, Korea, HK
NCT00390195 I/II Everolimus (weekly or daily) Any line Taiwan
NCT00920192 I/II Foretinib Any line Taiwan, HK
Combination Targeted Therapy
SEARCH
NCT00901901
III Sorafenib + erlotinib Sorafenib First-line International
NCT00881751 II Erlotinib + bevacizumab Sorafenib First-line US
NCT00365391 II Erlotinib + bevacizumab First- or second-line US
TCOGP-1209
NCT00971126
I/II Thalidomide + sorafenib First-line Taiwan
NCT00828594 I/II Everolimus + sorafenib Placebo + sorafenib First-line International
NCT00791544 I/II AVE1642* +/- sorafenib or erlotinib Any line France
Earlier-stage Disease
STORM
NCT00692770
III Sorafenib
Placebo
Adjuvant (post-resection or -local ablation) International
BRISK-TA
NCT00908752
III Brivanib + TACE
Placebo + TACE
BCLC B International
NCT00921531 III Thalidomide + TACE
TACE
BCLC A-B China
NCT00728078 II/III Thalidomide, low dose Adjuvant (post-RFA) China
START
NCT00990860
II Sorafenib + TACE BCLC B Taiwan
NCT00855218 II Sorafenib + TACE
Placebo + TACE
BCLC B International
COTSUN
NCT00919009
II Sorafenib + TACE TNM III/IVa Korea
NCT00576199 II Bevacizumab Pre- and Post-TACE HK
JLOG 0901
NCT00933816
I/II Sorafenib + fluorouracil/platinum HAI Not suitable for resection, ablation, TACE Japan
NCT00293436 I/II Erlotinib + celecoxib Adjuvant (post-resection, -TACE, or -RFA), high-risk US
  1. BSC, best supportive care; ECOG, Eastern Cooperative Oncology Group; HAI, hepatic arterial infusion; HK, Hong Kong; HOG, Hoosier Oncology Group; JLOG, Japan Liver Oncology Group; RFA, radiofrequency ablation; TACE, transarterial chemoembolization; US, United States; VEGF, vascular endothelial growth factor
  2. *Anti-insulin-like growth factor receptor-1 monoclonal antibody