Summary

Eligibility
for people ages 18-110 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around
Principal Investigator
by Farshid Dayyani (uci)

Description

Summary

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab and bevacizumab therapy in patients with locoregional hepatocellular carcinoma

Official Title

A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination With Either Durvalumab Monotherapy or Durvalumab Plus Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma (EMERALD-1)

Details

This is a randomized, double-blind, placebo-controlled, multicenter, global Phase III study to determine the efficacy and safety of transarterial chemoembolization (TACE) treatment in combination with durvalumab monotherapy or TACE given with durvalumab plus bevacizumab therapy compared to TACE therapy alone in patients with locoregional hepatocellular carcinoma not amenable to curative therapy

Keywords

Hepatocellular Carcinoma, TACE, Durvalumab, Bevacizumab, Liver Cancer, Liver Neoplasms, Transarterial Chemoembolization (TACE)

Eligibility

You can join if…

Open to people ages 18-110

  • No evidence of extrahepatic disease
  • Disease not amenable to curative surgery or transplantation or curative ablation but disease amenable to TACE
  • Child-Pugh score class A to B7 and Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
  • Measurable disease by Modified Response Criteria in Solid Tumors (mRECIST) criteria
  • Adequate organ and marrow function

You CAN'T join if...

  • Any history of nephrotic or nephritic syndrome
  • Clinically significant cardiovascular disease or history of arterioembolic event including a stroke or myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack within 6 months prior to randomization
  • Any prior or current evidence of coagulopathy or bleeding diathesis or patients who had any kind of surgery in the past 28 days (biopsies are exempt from this exclusion)
  • History of abdominal fistula or GI perforation, non healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment
  • Patients with Vp3 and Vp4 portal vein thrombosis on baseline imaging are excluded

Locations

  • Research Site
    La Jolla California 92093-0698 United States
  • Research Site
    Costa Mesa California 92627 United States
  • Research Site
    Orange California 92868 United States

Lead Scientist at University of California Health

  • Farshid Dayyani (uci)
    Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 134 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AstraZeneca
ID
NCT03778957
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 724 people participating
Last Updated