Clinical trial NCT01405573: Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
Official title: Sorafenib in the First Line Treatment of Advanced Hepatocellular Carcinoma With Child-Pugh Liver Function Class B: Multicentre Phase 3 Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Advanced Adult Hepatocellular Carcinoma
Keywords: Child Pugh B
first line
Lead sponsor: National Cancer Institute, Naples
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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.

Eligibility 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

Primary outcomes:
measure: overall survival
timeFrame: 6 months
Secondary outcomes:
measure: worst grade toxicity per patient
timeFrame: every 4 weeks
measure: quality of life
timeFrame: every 4 weeks for 6 months
measure: progression free survival
timeFrame: every 8 weeks
Other outcomes:
Locations:
city: Benevento
country: Italy
facility: Azienda Ospedaliera G. Rummo
state: BN
city: Palermo
country: Italy
facility: Policlinico Giaccone
state: PA
city: Bologna
country: Italy
facility: S. Orsola-Malpighi
city: Carpi
country: Italy
facility: Ospedale Ramazzini di Carpi
city: Faenza
country: Italy
facility: Osp. Civile Infermi
city: Firenze
country: Italy
facility: Azienda Ospedaliera Careggi
city: Genova
country: Italy
facility: IRCCS-Azienda Ospedaliera Universitaria San Martino-IST
city: Mantova
country: Italy
facility: AO C. Poma
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
city: Messina
country: Italy
facility: A.O.U. G.Martino- Policlinico Universita di Messina
city: Milano
country: Italy
facility: Istituto Nazionale Tumori
city: Napoli
country: Italy
facility: A.O.U. Federico II
city: Napoli
country: Italy
facility: AOU II Università di Napoli
city: Napoli
country: Italy
facility: Istituto Nazionale dei Tumori
city: Napoli
country: Italy
facility: Ospedale Cardarelli
city: Padova
country: Italy
facility: Azienda Ospedaliera Universitaria di Padova
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Palermo
country: Italy
facility: A.O. Ospedali Riuniti Villa Sofia-Cervello
city: Parma
country: Italy
facility: Azienda Ospedaliero Universitaria di Parma
city: Piacenza
country: Italy
facility: Ospedale Guglielmo da Saliceto
city: Potenza
country: Italy
facility: AO S. Carlo
city: Roma
country: Italy
facility: Policlinico Universitario Tor Vergata
city: S. Giovanni Rotondo
country: Italy
facility: Oncologia IRCCS - Casa Sollilevo Sofferenza
city: Sant'Anna di Ferrara
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica
city: Trevigilio
country: Italy
facility: A.O. Trevigilio - Caravaggio
Study officials:
affiliation: Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
name: Bruno Daniele, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
name: Francesco Perrone, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Second University of Naples, Italy; Chair of Medical Statistics
name: Ciro Gallo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Università Cattolica del S. Cuore, Policlinico Gemelli, Roma
name: Antonio Gasbarrini, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale Antonio Cardarelli, Napoli
name: Giacomo Carteni', M.D.
role: PRINCIPAL_INVESTIGATOR
References: