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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

Purpose

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.

Ages Eligible for Study:  18 years to 150 years (Adult, Older Adult)
Sexes Eligible for Study:  All
Acccepts Healthy Volunteers:  No

Inclusion Criteria

  • Histologically or cytologically, 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 both HBV and HCV, or co-infected with HBV and hepatitis D virus
  • Receipt of prior systemic anticancer therapy for HCC
  • Those on a waiting list for liver transplantation
Moses Raj, MD
Medical Oncology
Allegheny General Hospital
Forbes Hospital
Contact

For more information about this trial, please call (724) 705-0725 or send an email to ClinicalTrials@ahn.org.

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