Foie

TITRE	Étude multicentrique de phase III, à répartition aléatoire, à double insu et contrôlée par placebo visant à évaluer la chimio-embolisation transartérielle (CETA) combinée à une monothérapie par le durvalumab ou à un traitement d’association par le durvalumab et le bévacizumab chez des patients atteints d’un carcinome hépatocellulaire locorégional
PROTOCOLE ID	EMERALD-1
CLINICAL TRIAL.gov ID	NCT03778957
TYPE(S) DE CANCER	Foie
PHASE	Phase III
TYPE D'ÉTUDE	Traitement
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 to B7 and 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) Any history of nephrotic or nephritic syndrome Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion) History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded