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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