Foie

TITRE	(EN) A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination With Tremelimumab ± Lenvatinib Given Concurrently With TACE Compared to TACE Alone in Patients With Locoregional Hepatocellular Carcinoma
PROTOCOLE ID	EMERALD-3
CLINICAL TRIAL.gov ID	NCT05301842
TYPE(S) DE CANCER	Foie
PHASE	Phase III
TYPE D'ÉTUDE	Clinique
INSTITUTION	CHUM 1051 rue Sanguinet (514) 890-8000
VILLE	Montréal
INVESTIGATEUR(RICE) PRINCIPAL(E)	Hélène Castel
COORDONATEUR(RICE)	Joannie Blanchette joannie.blanchette.chum@ssss.gouv.qc.ca 514-890-8000 poste 36304
STATUT	Fermé
CRITÈRES D'ÉLIGIBILITÉ	(EN) No evidence of extrahepatic disease Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE Child Pugh score class A Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria Adequate organ and marrow function
CRITÈRES D'EXCLUSION	(EN) History of symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardia arrhythmia History of hepatic encephalopathy Major portal vein thrombosis visible on baseline imaging Uncontrolled arterial hypertension Co-infection with HBV and HDV