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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 (EMERALD-2)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507689-26-00
Acronym
D910DC00001
Enrollment
94
Registered
2024-03-19
Start date
2019-10-07
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

Histologically or cytologically confirmed Locoregional Hepatocellular Carcinoma (HCC) and successfully completed curative therapy (resection or ablation)

Brief summary

Recurrence-free survival (RFS)

Detailed description

Overall survival (OS) Time to recurrence (TTR) RFS at 24 months (RFS24) and RFS at 36 months (RFS36) Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)

Interventions

DRUGINFLIXIMAB
DRUGIMFINZI 50 mg/mL concentrate for solution for infusion.
DRUGBEVACIZUMAB
DRUGMYCOPHENOLATE MOFETIL
DRUGSODIUM CHLORIDE

Sponsors

Astrazeneca AB
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival (RFS)

Secondary

MeasureTime frame
Overall survival (OS) Time to recurrence (TTR) RFS at 24 months (RFS24) and RFS at 36 months (RFS36) Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)

Countries

Austria, France, Germany, Italy, Poland

Outcome results

None listed

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