🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT06040099
Active, not recruiting Phase 2

A US Study to Evaluate Transarterial Radioembolization (TARE) in Combination With Durvalumab and Bevacizumab Therapy in People With Unresectable Hepatocellular Carcinoma Amenable to TARE

NCT06040099 · tracked via the Priya Life Science USA tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2024-02-13
Last updated
2026-06-30

Condition(s) studied

Hepatocellular Carcinoma (HCC)

Investigational drug(s) / intervention(s)

Durvalumab →Bevacizumab →Transarterial Radioembolization (TARE)

Durvalumab: Durvalumab IV (intravenous)

Bevacizumab: Bevacizumab IV (intravenous)

Transarterial Radioembolization (TARE): Yttrium 90 glass microspheres will be administered

Study summary

The purpose of this study is to measure the efficacy and safety of durvalumab intravenous (IV) solution plus bevacizumab IV solution after transarterial radioembolization (Yttrium 90 glass microspheres TARE) in participants with unresectable hepatocellular carcinoma (HCC) amenable to embolization.

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion Criteria: * Participants with confirmed unresectable HCC * Participants with Lung dose threshold for Yttrium 90 glass microspheres of 30 Gy (equal or less than 30 Gy per treatment for glass) and an estimated Future liver remnant volume (FLRV) ≥ 30% of whole liver volume. * Participants with more than 1 prior embolization are permitted if more than 12 months ago, for a different primary lesion, and FLR \> 30%. * Participants with no evidence of extrahepatic disease on any available imaging * Participants with one or more measurable lesions, unilobar disease for participants with segmental or right anterior/posterior portal vein invasion (Vp1/Vp2) and eligible for Yttrium 90 glass microspheres TARE. * Participants having Child-Pugh score class A. * Participants having ECOG performance status of 0 or 1 at enrollment * Adequate organ and marrow function Exclusion Criteria: * Disease amenable to curative surgery, ablation or transplantation. Transplant patients are considered eligible if outside of Milan criteria and not currently listed for transplant. * Participants co-infected with HBV and HDV * Any history of nephrotic or nephritic syndrome. * Clinically significant (eg, active) cardiovascular disease * Participants with uncontrolled hypertension * History of hepatic encephalopathy * Known hereditary predisposition to bleeding or thrombosis; any prior or current evidence of bleeding diathesis. * Receipt of more than 1 prior embolization (TACE or TARE) treatment/procedure * Participant has received any prior anticancer systemic therapy for unresectable HCC. * History of arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months prior to enrollment. * History of abdominal fistula or gastrointestinal (GI) perforation, non-healed gastric ulcer that is refractory to treatment, or active GI bleeding within 6 months prior to enrollment

Primary outcome measure(s)

Trial sites (21)

FacilityCityRegionStatus
Research Site Aurora Colorado
Research Site Gainesville Florida
Research Site Orlando Florida
Research Site Atlanta Georgia
Research Site Atlanta Georgia
Research Site Chicago Illinois
Research Site Boston Massachusetts
Research Site Detroit Michigan
Research Site St Louis Missouri
Research Site Trenton New Jersey
Research Site Buffalo New York
Research Site New York New York
Research Site Chapel Hill North Carolina
Research Site Columbus Ohio
Research Site Portland Oregon
Research Site Philadelphia Pennsylvania
Research Site Houston Texas
Research Site Charlottesville Virginia
Research Site Seattle Washington
Research Site Milwaukee Wisconsin
Research Site Milwaukee Wisconsin

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Avastin (bevacizumab) drug profile →

More AstraZeneca trials in the USA

Other trials for the same condition

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 NCT06040099 on ClinicalTrials.gov ↗ ← All trials in the USA