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

Phase 3

Terminated

• Conditions: Advanced Adult Hepatocellular Carcinoma
• Interventions: Other: Best Supportive Care; Drug: sorafenib

• Registration Number: NCT01405573
• Lead Sponsor: National Cancer Institute, Naples

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.

Study Timeline

• Study First Submitted: 2010-02-26
• Study Start: 2011-07
• Study First Submitted QC: 2011-07-28
• Study First Posted: 2011-07-29
• Status Verified: 2017-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B: Sorafenib 400 mg, twice a day + Best Supportive Care	sorafenib	sorafenib + best supportive care
A: Best Supportive Care	Best Supportive Care	best supportive care
B: Sorafenib 400 mg, twice a day + Best Supportive Care	Best Supportive Care	sorafenib + best supportive care

Primary Outcome Measures

Name	Time	Method
overall survival	6 months

Secondary Outcome Measures

Name	Time	Method
worst grade toxicity per patient	every 4 weeks	worst grade toxicity (according to Common Terminology Criteria for Adverse Events version 4.03) per patient in both treatment arms
quality of life	every 4 weeks for 6 months
progression free survival	every 8 weeks

Trial Locations

Locations (25)

Ospedale Cardarelli; 🇮🇹 Napoli, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy

A.O. Ospedali Riuniti Villa Sofia-Cervello; 🇮🇹 Palermo, Italy

Ospedale Guglielmo da Saliceto; 🇮🇹 Piacenza, Italy

AO S. Carlo; 🇮🇹 Potenza, Italy

Azienda Ospedaliera Universitaria Arcispedal, U.O. di Oncologia Clinica; 🇮🇹 Sant'Anna di Ferrara, Italy

IRCCS-Azienda Ospedaliera Universitaria San Martino-IST; 🇮🇹 Genova, Italy

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, BN, Italy

Ospedale Ramazzini di Carpi; 🇮🇹 Carpi, Italy

Osp. Civile Infermi; 🇮🇹 Faenza, Italy

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori; 🇮🇹 Meldola, Italy

Policlinico Giaccone; 🇮🇹 Palermo, PA, Italy

Istituto Nazionale dei Tumori; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Universitaria di Padova; 🇮🇹 Padova, Italy

Azienda Ospedaliera Careggi; 🇮🇹 Firenze, Italy

A.O. Trevigilio - Caravaggio; 🇮🇹 Trevigilio, Italy

Azienda Ospedaliero Universitaria di Parma; 🇮🇹 Parma, Italy

Policlinico Universitario Tor Vergata; 🇮🇹 Roma, Italy

A.O.U. G.Martino- Policlinico Universita di Messina; 🇮🇹 Messina, Italy

A.O.U. Federico II; 🇮🇹 Napoli, Italy

AOU II Università di Napoli; 🇮🇹 Napoli, Italy

Oncologia IRCCS - Casa Sollilevo Sofferenza; 🇮🇹 S. Giovanni Rotondo, Italy

Istituto Nazionale Tumori; 🇮🇹 Milano, Italy

S. Orsola-Malpighi; 🇮🇹 Bologna, Italy

AO C. Poma; 🇮🇹 Mantova, Italy