Hepatocellular carcinoma: vascular abnormalities prior to, during and following systemic anti-cancer treatment
Phase 2
Recruiting
- Conditions
- liver cancer10019815
- Registration Number
- NL-OMON32482
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 28
Inclusion Criteria
advanced hepatocellular carcinoom.
Child-Pugh class B liver cirrhosis.
Exclusion Criteria
Major cardiac disease, HIV infection, serious active infectie
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. Progression-free survival (PFS) at 6 months measured by CT-scan at 3-months<br /><br>intervals<br /><br><br /><br>2. Assessment of circulating levels of microparticles derived from vascular<br /><br>and/or tumour cells, and plasma microparticles-tissue factor activity<br /><br><br /><br>3. Circulating levels of biomarkers of the vasculature including endothelium<br /><br>activation marker such as VCAM, L-CAM, and P-selectin<br /><br><br /><br>4. Investigation whether 2 and 3 are predictive factors for PFS and overall<br /><br>survival</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Objective complete and partial response rate (RECIST criteria)<br /><br><br /><br>2. Overall survival<br /><br><br /><br>3. One year survival rate<br /><br><br /><br>4. Safety<br /><br><br /><br>5. Alterations in cellular source of circulating MP during treatment as<br /><br>compared to pretreatment MP phenotype.<br /><br><br /><br>6. Assessment of development of venous thromboembolic events</p><br>