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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Advanced Adult Hepatocellular Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

overall survival

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Bruno Daniele, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology

Authority:

Italy: Ethics Committee

Study ID:

BOOST

NCT ID:

NCT01405573

Start Date:

July 2011

Completion Date:

March 2014

Related Keywords:

  • Advanced Adult Hepatocellular Carcinoma
  • Child Pugh B
  • first line
  • Carcinoma
  • Carcinoma, Hepatocellular

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