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

This study is currently recruiting participants.

Verified by TTY Biopharm, September 2005

First Received: September 21, 2005 No Changes Posted

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:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Contacts

Contact: Chin-Yin Hung, M.D

+886-25453105 ext 416

jessica@tty.com.tw

Locations

Taiwan
Taiwan Cooperative Oncology Group	Recruiting
Taipei, Taiwan
Contact: Yung-Hsiung Chin, M.D. +886-2-26534401 ext 25157 yhchin@nhri.org.tw
Principal Investigator: Li-Tzong Chen, M.D. Ph.D.

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

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

Keywords provided by TTY Biopharm:

Phase III
Hepatocellular Carcinoma

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Thalidomide
Immunologic Factors
Carcinoma, Hepatocellular
Antineoplastic Agents
Physiological Effects of Drugs
Liver Neoplasms
Anti-Bacterial Agents
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

Digestive System Neoplasms
Neoplasms by Histologic Type
Growth Substances
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Leprostatic Agents

ClinicalTrials.gov processed this record on November 20, 2009