Groupe d'Etude en Oncologie du Quebec

Titre	A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation
Protocole ID	EMERALD-2
ClinicalTrials.gov ID	NCT03847428
Type(s) de cancer	Foie
Phase	Phase III
Type étude	Traitement
Médicament	Durvalumab monothérapie ou combiné au Bevacizumab
Institution	CHU DE QUEBEC – UNIVERSITE LAVAL L'HOTEL-DIEU DE QUEBEC ET CRCEO 11 Côte du Palais, Québec, QC, G1R 2J6
Ville	Québec
Investigateur(trice) principal(e)	Dr Maxime Chénard-Poirier
Coordonnateur(trice)	Maryse Gingras 418-691-5781
Statut	Fermé
Critètes d'éligibilité	Histologically or cytologically, newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation) Imaging to confirm disease-free status within 28 days prior to randomization ECOG 0-1 at enrolment Child-Pugh score of 5 or 6 Adequate organ and marrow function
Critètes d'exclusion	Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging History of hepatic encephalopathy within 12 months prior to randomization Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded Active co-infection with both HBV and HCV, or co-infected with HBV and hepatitis D virus Receipt of prior systemic anticancer therapy for HCC Those on a waiting list for liver transplantation

Groupe d'étude en oncologie du Québec