Groupe d'Etude en Oncologie du Quebec

Titre	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
ClinicalTrials.gov ID	NCT05301842
Type(s) de cancer	Foie
Phase	Phase III
Type étude	Clinique
Médicament	Durvalumab en association avec tremelimumab ± lenvatinib concomitant avec TACE comparé au TACE seul
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
Ville	Montréal
Investigateur(trice) principal(e)	Dre Hélène Castel
Coordonnateur(trice)	Joannie Blanchette 514-890-8000 poste 36304
Statut	Actif en recrutement
Date d'activation	21-10-2022
Critètes d'éligibilité	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
Critètes d'exclusion	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

Groupe d'étude en oncologie du Québec