Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
- Conditions
- Advanced Adult Hepatocellular Carcinoma
- Interventions
- Other: Best Supportive Care
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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)
Azienda Ospedaliera G. Rummo
🇮🇹Benevento, BN, Italy
Policlinico Giaccone
🇮🇹Palermo, PA, 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
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