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

This study has been terminated.

( slowly recruitment rate )

First Received on September 21, 2005. Last Updated on October 7, 2011 History of Changes

Sponsor:	TTY Biopharm
Information provided by:	TTY Biopharm
ClinicalTrials.gov Identifier:	NCT00225290

Purpose

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

Condition	Intervention	Phase
Carcinoma, Hepatocellular	Drug: Thalidomide(Thado)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Double-blind, Placebo-controlled, Randomized Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve

Resource links provided by NLM:

Drug Information available for: Thalidomide

U.S. FDA Resources

Further study details as provided by TTY Biopharm:

Primary Outcome Measures:

overall survival

Estimated Enrollment:	230
Study Start Date:	February 2003

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with measurable, metastatic or locally advanced hepatocellular carcinoma
The diagnosis of HCC should be established either by cyto/histology
Patients must be > 20 years of age.
ECOG score < 2.
Signed informed consent.
Female patients at child-bearing age must have negative pregnancy test.

Exclusion Criteria:

Patients with other systemic diseases which require concurrent usage of glucocorticosteroid or immunosuppressant agent(s) are not eligible.
Patients with advanced second primary malignancy are not eligible.
Patients with active infection are not eligible.
Patients with pregnancy or breast-feeding are not eligible.
Patients with brain metastases are not eligible.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225290

Locations

Taiwan
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

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00225290 History of Changes
Other Study ID Numbers:	T2202
Study First Received:	September 21, 2005
Last Updated:	October 7, 2011
Health Authority:	Taiwan: Department of Health

Keywords provided by TTY Biopharm:

Phase III
Hepatocellular Carcinoma

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Thalidomide
Immunosuppressive Agents

Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012