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


Phase 3
20 Years
N/A
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

overall survival

Principal Investigator

Li-Tzong Chen, M.D Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Cancer Research, National Health Research Institute Ward 191

Authority:

Taiwan: Department of Health

Study ID:

T2202

NCT ID:

NCT00225290

Start Date:

February 2003

Completion Date:

Related Keywords:

  • Carcinoma, Hepatocellular
  • Phase III
  • Hepatocellular Carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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