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CompletedLast updated: 1 February 2024

EMERALD-2: This phase III trial evaluates the effectiveness and safety of using a targeted therapy (Durvalumab), either alone or in combination with another targeted therapy (Bevacizumab), to extend remission in patients who have a high risk of hepatocellular carcinoma recurrence post curative treatmentA 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

Clinical summary

Summary

Patients eligible to participate in this trial will receive intravenous administration of either Durvalumab and Bevacizumab, Durvalumab and a Bevacizumab placebo, or two placebos.

Conditions

This trial is treating patients with Hepatocellular Carcinoma.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

EMERALD-2

More information

Trial Identifiers

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Trial sponsor

AstraZeneca

Scientific 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

Eligibility

Inclusion

  • 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

  • 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

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
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Clinical trials have complex eligibility criteria.

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