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

TTY Biopharm

Status and phase: Terminated; Phase 3

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Thalidomide(Thado)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00225290

T2202

Details and patient eligibility

About

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

Enrollment: 230 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind