US Study on Combining TARE with Durvalumab and Bevacizumab for Treating Unresectable Liver Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06040099

Provider View

This clinical trial is testing a new treatment approach for people with liver cancer that cannot be removed by surgery. The study combines a special type of radiation therapy called TARE with two medications, Durvalumab and Bevacizumab, to see if it is safe and effective.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of combining Durvalumab and Bevacizumab, both given through an IV, after a procedure called transarterial radioembolization (TARE) using Yttrium 90 glass microspheres. This treatment is for patients with liver cancer that cannot be surgically removed but can be treated with TARE.

Description

This Phase II study involves participants with liver cancer that cannot be removed by surgery but can be treated with a procedure called embolization. The study is for those who are not eligible for or have chosen not to undergo surgery, ablation, or liver transplant. Participants who have had previous treatments like Transarterial Chemoembolization (TACE) or TARE in a curative setting can join if there has been a 6-month gap since their last treatment.

The study plans to enroll about 125 participants across 20 sites in the US, focusing on treating around 100 participants with this new combination therapy.

Eligibility Criteria

Inclusion Criteria

  • Have liver cancer that cannot be removed by surgery.
  • Meet specific safety criteria for the radiation treatment, including a lung dose threshold of 30 Gy or less and a future liver remnant volume of at least 30%.
  • No signs of cancer outside the liver on imaging tests.
  • Have one or more measurable tumors and specific types of liver involvement that can be treated with TARE.
  • Have a Child-Pugh score class A, indicating good liver function.
  • Have an ECOG performance status of 0 or 1, meaning fully active or with some restrictions but able to do light work.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • Cancer that can be treated with surgery, transplant, or ablation.
  • Co-infection with hepatitis B and D viruses.
  • History of kidney problems like nephrotic or nephritic syndrome.
  • Significant heart disease or uncontrolled high blood pressure.
  • History of liver-related brain issues (hepatic encephalopathy).
  • Known bleeding or clotting disorders.
  • More than one previous embolization treatment.
  • Previous systemic cancer treatment for liver cancer.
  • Recent history (within 6 months) of serious heart or blood vessel problems, such as heart attack or stroke.
  • Recent history (within 6 months) of abdominal issues like fistulas, non-healing ulcers, or active bleeding.

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