Clinical Trial Detail

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

Cancer - Liver Hepatocellular perihilar cholangiocarcinoma

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

NCT: NCT03847428

Moses Raj, MD

Medical Oncology

Allegheny General Hospital

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Forbes Hospital

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Contact

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

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