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

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT03778957

This Phase III study assesses the efficacy and safety of TACE with durvalumab, with or without bevacizumab, versus TACE alone in patients with locoregional hepatocellular carcinoma. Eligible patients must have no extrahepatic disease, be unsuitable for curative treatment, and meet specific health criteria. Interventions include durvalumab, bevacizumab, placebo, and TACE.

Patient Parameters

Program Overview

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

Description

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

Eligibility Criteria

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

Key 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

Locations

FACILITYZIPCITYSTATE
Research Site92627Costa MesaCalifornia
Research Site92093-0698La JollaCalifornia
Research Site92868OrangeCalifornia
Research Site20007Washington D.C.District of Columbia
Research Site32224JacksonvilleFlorida
Research Site33136MiamiFlorida
Research Site96819HonoluluHawaii
Research Site60612ChicagoIllinois
Research Site71103ShreveportLouisiana
Research Site48201DetroitMichigan

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