Titre 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
Type(s) de cancer Foie
Phase Phase III
Type étude Traitement
Médicament Chimioembolisation transartérielle avec durvalumab seul ou en association avec le bévacizumab
Ville Montréal
Investigateur(trice) principal(e) Dre Hélène Castel
Coordonnateur(trice) Joannie Blanchette
 514-890-8000 poste 36304
Statut Actif en recrutement
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 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
Critètes d'exclusion
  • 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