Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma

Advanced Adult Hepatocellular Carcinoma Clinical Trial

— BOOST  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01405573
• Other study ID #: BOOST
• Secondary ID: EudraCT number 2
• Status: Terminated
• Phase: Phase 3
• First received: February 26, 2010
• Last updated: March 27, 2017
• Start date: July 2011
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: National Cancer Institute, Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (HCC) with impaired liver function (Child B).

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Adult Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Other:
• Best Supportive Care
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.

Drug:
• sorafenib
400 mg twice a day

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera G. Rummo	Benevento	BN
Italy	S. Orsola-Malpighi	Bologna
Italy	Ospedale Ramazzini di Carpi	Carpi
Italy	Osp. Civile Infermi	Faenza
Italy	Azienda Ospedaliera Careggi	Firenze
Italy	IRCCS-Azienda Ospedaliera Universitaria San Martino-IST	Genova
Italy	AO C. Poma	Mantova
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola
Italy	A.O.U. G.Martino- Policlinico Universita di Messina	Messina
Italy	Istituto Nazionale Tumori	Milano
Italy	A.O.U. Federico II	Napoli
Italy	AOU II Università di Napoli	Napoli
Italy	Istituto Nazionale dei Tumori	Napoli
Italy	Ospedale Cardarelli	Napoli
Italy	Azienda Ospedaliera Universitaria di Padova	Padova
Italy	Istituto Oncologico Veneto	Padova
Italy	A.O. Ospedali Riuniti Villa Sofia-Cervello	Palermo
Italy	Policlinico Giaccone	Palermo	PA
Italy	Azienda Ospedaliero Universitaria di Parma	Parma
Italy	Ospedale Guglielmo da Saliceto	Piacenza
Italy	AO S. Carlo	Potenza
Italy	Policlinico Universitario Tor Vergata	Roma
Italy	Oncologia IRCCS - Casa Sollilevo Sofferenza	S. Giovanni Rotondo
Italy	Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica	Sant'Anna di Ferrara
Italy	A.O. Trevigilio - Caravaggio	Trevigilio

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute, Naples

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		6 months
Secondary	worst grade toxicity per patient	worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 4.03) per patient in both treatment arms	every 4 weeks
Secondary	quality of life		every 4 weeks for 6 months
Secondary	progression free survival		every 8 weeks