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NCT Number: NCT03847428

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

A global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab alone in patients with hepatocellular carcinoma who are at high risk of recurrence.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–150 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Kogarah, Australia

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About this study

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center, global study to assess the efficacy and safety of durvalumab in combination with bevacizumab or durvalumab monotherapy or placebo as adjuvant therapy. This study will be conducted in patients with HCC who are at high risk of recurrence after curative hepatic resection or ablation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically (or radiologically for patients undergoing curative ablation), newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
  • Imaging to confirm disease-free status within 28 days prior to randomization
  • ECOG 0-1 at enrolment
  • Child-Pugh score of 5 or 6
  • Adequate organ and marrow function.

Exclusion criteria

  • Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
  • Evidence of metastasis, macrovascular invasion or co-existing malignant disease on baseline imaging
  • History of hepatic encephalopathy within 12 months prior to randomization
  • Evidence, by Investigator assessment, of varices at risk of bleeding on upper endoscopy or contrast-enhanced cross-sectional imaging
  • Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
  • Active co-infection with HBV and HDV.
  • Receipt of prior systemic anticancer therapy for HCC
  • Those on a waiting list for liver transplantation

Treatment and study plan

Durvalumab

Drug

Durvalumab IV (intravenous)

Other names: IMFINZI

Bevacizumab

Drug

Bevacizumab IV (intravenous)

Other names: AVASTIN

Placebo

Other

Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking

Primary outcomes

  1. Recurrence-free survival (RFS) for Arm A vs Arm C

    Time frame: Up to 49 months after first patient randomized

    RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.

Secondary outcomes

  1. Recurrence-free survival (RFS) Arm B vs Arm C

    Time frame: Up to 49 months after first patient randomized

    RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.

  2. Overall Survival (OS) for Arm A vs Arm C and Arm B vs Arm C

    Time frame: No timeframe

    OS is defined as the time from the date of randomization until death due to any cause

  3. Recurrence-free survival at 24 months (RFS24) and 36 months (RFS36) for Arm A vs Arm C and Arm B vs Arm C

    Time frame: At 24 and at 36 months

    Proportion of RFS at 24 months and at 36 months

  4. Time to recurrence (TTR) for Arm A vs Arm C and Arm B vs Arm C

    Time frame: Up to 49 months after first patient randomized

    TTR is defined as the time from the date of randomization until the date of disease recurrence

  5. Time from randomization to recurrence/progression on next therapy (RFS2/PFS2) for Arm A vs Arm C and Arm B vs Arm C

    Time frame: Up to 49 months after first patient randomized

    Time from randomization to recurrence/progression on next therapy (RFS2/PFS2)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: EMERALD-2

Important dates

Study start
2019
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2019
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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