Exploratory study for biomarkers to predict efficacy and toxicity to Sorafenib in patients with advanced hepatocellular carcinoma
- Conditions
- Hepatocellulara carcinoma
- Registration Number
- JPRN-UMIN000008808
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 100
Not provided
1. Ineligible for dynamic CT or MRI; 2. Patients with cerebral metastasis; 3. Pregnant and breastfeeding women or those who may possibly be pregnant; 4. Patients with uncontrollable hypertension (BP>170 mmHg under medication) or with thromboembolism, ischemic heart disease, unstable angina pectoris, heart failure, or cerebrovascular disorder; 5. Patients with moderate or severe renal dysfunction (Ccr < 30 mL/min) including those on dialysis; 6. Patients with esophageal varices that may cause bleeding (those who had gastrointestinal bleeding in the past month); 7. Patients under treatment with drugs affecting the activity of CYP3A4 or UGT1A9 (e.g., carbamazepine, rifampicin, St. John's wort, etc. ) or drugs that may affect the serum concentration of sorafenib; 8. Patients with diseases related to human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); or 9. Patients judged as ineligible by the investigator in charge for other reasons
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate correlation between genome/protein/metabolites biomarker candidate and efficacy/incidence of adverse events
- Secondary Outcome Measures
Name Time Method