Spots Global Cancer Trial Database for Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma
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Trial Identification
Brief Title: 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 ID: NCT01405573
Conditions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
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
Contact Details
Name: Bruno Daniele, M.D.
Affiliation: Azienda Sanitaria Rummo, Benevento, Division of Medical Oncology
Role: PRINCIPAL_INVESTIGATOR
Name: Francesco Perrone, M.D., Ph.D
Affiliation: National Cancer Institute Naples, Italy; Director Clinical Trials Unit
Role: PRINCIPAL_INVESTIGATOR
Name: Ciro Gallo, M.D., Ph.D
Affiliation: Second University of Naples, Italy; Chair of Medical Statistics
Role: PRINCIPAL_INVESTIGATOR
Name: Antonio Gasbarrini, M.D.
Affiliation: Università Cattolica del S. Cuore, Policlinico Gemelli, Roma
Role: PRINCIPAL_INVESTIGATOR
Name: Giacomo Carteni', M.D.
Affiliation: Ospedale Antonio Cardarelli, Napoli
Role: PRINCIPAL_INVESTIGATOR
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