Status:
TERMINATED
Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
Lead Sponsor:
National Cancer Institute, Naples
Conditions:
Advanced Adult Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma ...
Detailed Description
Hepatocellular carcinoma (HCC) is the third cause of death for cancer in the world with an increasing incidence. No systemic therapy has proven effective in patients with advanced HCC until 2007, when...
Eligibility Criteria
Inclusion
- Patients with diagnosis of hepatic cell carcinoma (HCC) according to the AASLD- EASL criteria
- Age \>18 years
- Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments)
- Liver function classified as Child-Pugh class B
- ECOG performance status \< or = 2
- Life expectancy of at least 2 months
- Adequate contraception for fertile male and female patients
- Signed informed consent
Exclusion
- Prior exposure to sorafenib or antiangiogenesis drugs
- Concomitant diseases that contraindicate the use of sorafenib
- Gastro-intestinal bleeding in the previous 30 days
- Altered renal function(creatinine \> 1.5 x ULN), or haematological function (platelet count \< 60 x 10\^9/L, hemoglobin \< 9 g/dl)
- Serious active infections (\> grade 2 CTCAE version 3.0)
- Congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
- Patients who are unable or unwilling to participate in the study
- Pregnant or lactating females
- Hepatic encephalopathy of any grade
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01405573
Start Date
July 1 2011
End Date
March 1 2017
Last Update
March 28 2017
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Azienda Ospedaliera G. Rummo
Benevento, BN, Italy
2
Policlinico Giaccone
Palermo, PA, Italy, 90127
3
S. Orsola-Malpighi
Bologna, Italy
4
Ospedale Ramazzini di Carpi
Carpi, Italy