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

Carcinoma, Hepatocellular Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00225290
• Other study ID #: T2202
• Status: Terminated
• Phase: Phase 3
• First received: September 21, 2005
• Last updated: October 7, 2011
• Start date: February 2003

Study information

• Verified date: September 2005
• Source: TTY Biopharm
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 230
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Thalidomide(Thado)

Locations

Country	Name	City	State
Taiwan	Taiwan Cooperative Oncology Group	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
TTY Biopharm

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival