EMERALD-2

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224793

Enrollment

Registered

2019-07-19

Start date

2019-07-31

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hepatocellular Carcinoma

Interventions

investigational material(s) Generic name etc : Durvalumab (Genetical Recombination) INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration

Eligibility

Sex/Gender

All

Inclusion criteria

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

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, or 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

Design outcomes

Primary

Measure	Time frame
efficacy -	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics -	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026