Phase III Trial of Oral Thalidomide in Advanced Hepatocellular Carcinoma With Poor Liver Reserve
Phase 3
Terminated
- Conditions
- Carcinoma, Hepatocellular
- Registration Number
- NCT00225290
- Lead Sponsor
- TTY Biopharm
- Brief Summary
To compare the overall survival of thalidomide- and placebo-treated advanced HCC patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 230
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Taiwan Cooperative Oncology Group
🇨🇳Taipei, Taiwan