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

• Sponsor: TTY Biopharm (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00225290
• Collaborator: (none)
• Enrollment: 230
• Location: 1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Hepatocellular	Drug: Thalidomide(Thado)	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 230 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
• Study Start Date: Feb 1, 2003

Outcome Measures

Primary Outcome Measures

1. overall survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taiwan Cooperative Oncology Group	Taipei		Taiwan

Sponsors and Collaborators

• TTY Biopharm

Investigators

• Principal Investigator: Li-Tzong Chen, M.D Ph.D., Division of Cancer Research, National Health Research Institute Ward 191

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00225290
• Other Study ID Numbers: T2202
• First Posted: Sep 23, 2005
• Last Update Posted: Oct 12, 2011
• Last Verified: Sep 1, 2005

• Keywords provided by , ,: Phase III; Hepatocellular Carcinoma
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Thalidomide

Study Results

No Results Posted as of Oct 12, 2011