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Active, not recruiting Phase 3

Assess Efficacy and Safety of Durvalumab Alone or Combined With Bevacizumab in High Risk of Recurrence HCC Patients After Curative Treatment

NCT03847428 · tracked via the Priya Life Science Italy tracker
Phase
Phase 3
Started
2019-04-29
Last updated
2026-08-14

Condition(s) studied

Hepatocellular Carcinoma

Investigational drug(s) / intervention(s)

Durvalumab →Bevacizumab →Placebo

Durvalumab: Durvalumab IV (intravenous)

Bevacizumab: Bevacizumab IV (intravenous)

Placebo: Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous) or Dextrose for Durvalumab masking

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
150 Years
Healthy volunteers
No
Inclusion Criteria: * Histologically or cytologically (or radiologically for patients undergoing curative ablation), 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 HBV and HDV. * Receipt of prior systemic anticancer therapy for HCC * Those on a waiting list for liver transplantation

Primary outcome measure(s)

  • Recurrence-free survival (RFS) for Arm A vs Arm C — Up to 49 months after first patient randomized
    RFS (per RECIST 1.1 criteria as assessed by BICR) will be defined as the time from the date of randomization until the date of the first objective radiologic recurrence or death due to any cause, whichever occurs first.

Trial sites (217)

FacilityCityRegionStatus
Research Site Birmingham Alabama
Research Site Mobile Alabama
Research Site Phoenix Arizona
Research Site Costa Mesa California
Research Site La Jolla California
Research Site Long Beach California
Research Site Orange California
Research Site Sacramento California
Research Site Washington D.C. District of Columbia
Research Site Miami Florida
Research Site Tampa Florida
Research Site Honolulu Hawaii
Research Site Chicago Illinois
Research Site Westwood Kansas
Research Site Louisville Kentucky
Research Site Shreveport Louisiana
Research Site Detroit Michigan
Research Site Grand Rapids Michigan
Research Site Rochester Minnesota
Research Site Omaha Nebraska
Research Site New Brunswick New Jersey
Research Site Albuquerque New Mexico
Research Site New York New York
Research Site Stony Brook New York
Research Site Durham North Carolina
Research Site Winston-Salem North Carolina
Research Site Cleveland Ohio
Research Site Philadelphia Pennsylvania
Research Site Pittsburgh Pennsylvania
Research Site Spartanburg South Carolina
Research Site Knoxville Tennessee
Research Site Memphis Tennessee
Research Site Dallas Texas
Research Site Madison Wisconsin
Research Site Kogarah Australia
Research Site Melbourne Australia
Research Site Nedlands Australia
Research Site Westmead Australia
Research Site Innsbruck Austria
Research Site Linz Austria

+ 177 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03847428 on ClinicalTrials.gov ↗ ← All trials in Italy