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 (EMERALD-1)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509053-32-00

Acronym

EMERALD-1

Enrollment

Registered

2024-02-16

Start date

2019-07-17

Completion date

Unknown

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locoregional Hepatocellular Carcinoma (HCC)

Brief summary

Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR

Detailed description

Overall Survival (OS). Objective Response Rate (ORR). Disease Control Rate (DCR). Duration of Response (DoR). Time to progression (TTP). Time from Randomization to Second Progression PFS (PFS2). Health-related quality of life (HRQoL) patient reported outcomes.

Interventions

DRUGINFLIXIMAB

DRUGMYCOPHENOLATE MOFETIL

DRUGPlacebo

DRUGBEVACIZUMAB

DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Overall Survival (OS). Objective Response Rate (ORR). Disease Control Rate (DCR). Duration of Response (DoR). Time to progression (TTP). Time from Randomization to Second Progression PFS (PFS2). Health-related quality of life (HRQoL) patient reported outcomes.	—

Primary

Measure	Time frame
Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR	—

Countries

France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026