Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
NCT ID: NCT01405573
Last Updated: 2017-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
35 participants
INTERVENTIONAL
2011-07-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Best Supportive Care
best supportive care
Best Supportive Care
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
B: Sorafenib 400 mg, twice a day + Best Supportive Care
sorafenib + best supportive care
Best Supportive Care
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
sorafenib
400 mg twice a day
Interventions
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Best Supportive Care
Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
sorafenib
400 mg twice a day
Eligibility Criteria
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Inclusion 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
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute, Naples
OTHER
Responsible Party
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Principal Investigators
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Bruno Daniele, M.D.
Role: PRINCIPAL_INVESTIGATOR
Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
Francesco Perrone, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Ciro Gallo, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Second University of Naples, Italy; Chair of Medical Statistics
Antonio Gasbarrini, M.D.
Role: PRINCIPAL_INVESTIGATOR
Università Cattolica del S. Cuore, Policlinico Gemelli, Roma
Giacomo Carteni', M.D.
Role: PRINCIPAL_INVESTIGATOR
Ospedale Antonio Cardarelli, Napoli
Locations
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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
Florence, , 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
Milan, , 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
Padua, , Italy
Istituto Oncologico Veneto
Padua, , Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello
Palermo, , 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, , Italy
Countries
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Other Identifiers
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EudraCT number 2009-013870-42
Identifier Type: REGISTRY
Identifier Source: secondary_id
BOOST
Identifier Type: -
Identifier Source: org_study_id
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