Treatment of advanced liver cell cancer with the drug thymostimuli
Phase 2
Completed
- Conditions
- ocally advanced or metastasised hepatocellular carcinomaCancerHepatocellular carcinoma
- Registration Number
- ISRCTN29319366
- Lead Sponsor
- Martin-Luther-University Halle-Wittenberg (Germany)
- Brief Summary
2008 results in https://pubmed.ncbi.nlm.nih.gov/18366627/ (added 30/12/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
Inclusion Criteria
1. Biopsy- or image-proven locally advanced or metastatic hepatocellular carcinoma not amenable to or failing established treatment
2. Two-dimensional measurable lesion on imaging
3. Life expectancy greater than 3 months
4. Age 18 to 80 years
Exclusion Criteria
1. Pregnancy/lactation
2. Active second malignancy
3. Severe concomitant disease (e.g. New York Heart Association [NYHA] grade III - IV, serum creatinine level greater than 300 µmol/l)
4. Severe decompensated liver function (bilirubin greater than 5 mg/dl, International normalised ratio [INR] greater than or equal to 2.3)
5. Unable to give informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival as well as 1-, 2- and 3-year survival.
- Secondary Outcome Measures
Name Time Method <br> 1. Tumour response and progression-free survival according to standard World Health Organization (WHO) criteria. Timepoints are:<br> 1.1. Tumour response end of study (three years)<br> 1.2. Overall progression-free survival<br> 2. Toxicity according to Eastern Cooperative Oncology Group (ECOG) criteria<br>