Status:
TERMINATED
Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
Lead Sponsor:
TTY Biopharm
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00225290
Start Date
February 1 2003
Last Update
October 12 2011
Active Locations (1)
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1
Taiwan Cooperative Oncology Group
Taipei, Taiwan