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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Brief Summary

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

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Thalidomide(Thado)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Division of Cancer Research, National Health Research Institute Ward 191

Locations

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Taiwan Cooperative Oncology Group

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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T2202

Identifier Type: -

Identifier Source: org_study_id