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

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

Taiwan

Study Type

Interventional

Intervention

Thalidomide(Thado)

About this trial

This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Phase III, Hepatocellular Carcinoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Taiwan Cooperative Oncology Group

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00225290

First Posted

September 21, 2005

Last Updated

October 7, 2011

Sponsor

TTY Biopharm

1. Study Identification

Unique Protocol Identification Number

NCT00225290

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Terminated

Why Stopped

slowly recruitment rate

Study Start Date

February 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

TTY Biopharm

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma, Hepatocellular

Keywords

Phase III, Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

230 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Thalidomide(Thado)

Primary Outcome Measure Information:

Title

overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

No

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Division of Cancer Research, National Health Research Institute Ward 191

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taiwan Cooperative Oncology Group

City

Taipei

Country

Taiwan

Carcinoma, Hepatocellular

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial