Trial | NCT01405573  Report issue

Title

Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    sorafenib ...

  • Study Participants

    35
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 (HCC) with impaired liver function (Child B).
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 results of the SHARP trial were presented. In this trial, the orally active multi-kinase inhibitor sorafenib (800 mg/day) significantly prolonged survival compared with placebo in patients with advanced HCC and good liver function (Child A). The same authors concluded that the effect of the drug in the population of patients with more impaired liver function should be further studied.
Study Started
Jul 31
2011
Primary Completion
Mar 31
2017
Study Completion
Mar 31
2017
Last Update
Mar 28
2017

Other Best Supportive Care

Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.

Drug sorafenib

400 mg twice a day

A: Best Supportive Care Active Comparator

best supportive care

B: Sorafenib 400 mg, twice a day + Best Supportive Care Experimental

sorafenib + best supportive care

Criteria 

Inclusion Criteria:

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 Criteria:

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
No Results Posted