Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve

Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve

To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.

Inclusion Criteria:

1. Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
2. The diagnosis of HCC should be established either by cyto/histology
3. Patients must be > 20 years of age.
4. ECOG score < 2.
5. Signed informed consent.
6. Female patients at child-bearing age must have negative pregnancy test.

Exclusion Criteria:

1. Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
2. Patients with advanced second primary malignancy are not eligible.
3. Patients with active infection are not eligible.
4. Patients with pregnancy or breast-feeding are not eligible.
5. Patients with brain metastases are not eligible.