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
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