A randomized phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma.
Recruiting
- Conditions
- hepatocellular cancer
- Registration Number
- NL-OMON21497
- Lead Sponsor
- ot applicable
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Histologically proven HCC, irresectable tumor, failure to previous treatment, WHO 0-2, at least 4 weeks since prior treatment with HMG-Coa reductase inhibitors or systemic immunosuppresiva, adequate hepatic and bone marrow function.
Exclusion Criteria
Prior treatment with doxorubicin or thalidomide, uncontrolled hypertension, unstable angina, arrhythmias requiring treatment, MI, thrombo-embolic events requiring treatment, congestive heartfailure or cardiomyopathy requiring treatment, peripheral neuropathy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The 1-year survival.
- Secondary Outcome Measures
Name Time Method Response rate scored according to RECIST criteria, time to progression, quality of life, and toxicity.