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A Global Study to Evaluate Transarterial Chemoembolization (TACE) in Combination With Durvalumab and Bevacizumab Therapy in Patients With Locoregional Hepatocellular Carcinoma

Trial Status: Active

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

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

California

Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: ACTIVE
Contact: Carmen Lu
Phone: 714-456-8442
San Diego
University of California San Diego
Status: ACTIVE

Colorado

Aurora
University of Colorado Hospital
Status: CLOSED_TO_ACCRUAL

Florida

Jacksonville
Mayo Clinic in Florida
Status: ACTIVE
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: COMPLETED

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: ACTIVE

Kansas

Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Benjamin R. Roberts
Phone: 913-588-6939

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Massachusetts General Hospital Cancer Center
Status: ACTIVE

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL

Minnesota

Rochester
Mayo Clinic in Rochester
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: ADMINISTRATIVELY_COMPLETE

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: IN_REVIEW

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: ACTIVE
Contact: Marcella West Aguilar
Phone: 214-648-1479

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

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D933GC00001
  • Secondary IDs NCI-2019-04890, 2018-002134-20
  • Clinicaltrials.gov ID NCT03778957