Groupe d'Etude en Oncologie du Quebec

Title	A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma
Protocole ID	EMERALD-1
ClinicalTrials.gov ID	NCT03778957
Cancer Type(s)	Liver
Phase	Phase III
Stage
Study Type	Treatment
Drug	Chimioembolisation transartérielle avec durvalumab seul ou en association avec le bévacizumab
Institution	CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
City
Principal Investigator	Dr. Hélène Castel
Coordinator	Joannie Blanchette 514-890-8000 poste 36304
Status	Recruiting
Activation Date
Eligibility Criteria	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
Exclusion Criteria	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

Groupe d'étude en oncologie du Québec