Assess efficacy and safety of Durvalumab alone or combined with Bevacizumab in high risk of recurrence HCC patients after curative treatment - EMERALD-2

Study identifier:D910DC00001

ClinicalTrials.gov identifier:NCT03847428

EudraCT identifier:2018-004105-85

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Hepatocellular Carcinoma

Phase

Phase 3

Healthy volunteers

No

Study drug

Durvalumab, Bevacizumab

Sex

All

Actual Enrollment

908

Study type

Interventional

Age

18 Years - 150 Years

Date

Study Start Date: 29 Apr 2019
Estimated Primary Completion Date: 29 May 2026
Estimated Study Completion Date: 31 May 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Apr 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria