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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00225290

Enrollment

230

Registered

2005-09-23

Start date

2003-02-28

Completion date

Unknown

Last updated

2011-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular

Keywords

Phase III, Hepatocellular Carcinoma

Brief summary

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

Interventions

DRUGThalidomide(Thado)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
overall survival	—

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026