Title

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
  • Phase

    Phase 3
  • Study Type

    Interventional
  • Status

    Terminated
  • Intervention/Treatment

    thalidomide ...
  • Study Participants

    230
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
Study Started
Feb 28
2003
Last Update
Oct 12
2011
Estimate

Drug Thalidomide(Thado)

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
Patients with advanced second primary malignancy are not eligible.
Patients with active infection are not eligible.
Patients with pregnancy or breast-feeding are not eligible.
Patients with brain metastases are not eligible.
No Results Posted