Study on Combining Durvalumab, Tremelimumab, and Lenvatinib with TACE for Patients with Localized Liver Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05301842

Provider View

This international clinical trial is testing a combination of treatments, including TACE, durvalumab, tremelimumab, and lenvatinib, to see if they can improve outcomes for patients with localized liver cancer that cannot be treated with surgery or other curative methods.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of combining TACE (a procedure that delivers chemotherapy directly to the liver) with the drugs durvalumab, tremelimumab, and lenvatinib in patients with localized liver cancer (HCC) that cannot be cured with surgery, transplantation, or ablation. The trial will compare this combination treatment to TACE alone to see which is more effective.

Description

This Phase III study involves multiple centers around the world and includes three groups of participants. Each group will receive different combinations of treatments to assess their effectiveness and safety. The treatments being tested include TACE, which is a procedure that targets liver tumors with chemotherapy, and the drugs durvalumab, tremelimumab, and lenvatinib. The study is open-label, meaning both the participants and researchers know which treatments are being given, but the sponsor of the study is blinded to the specific treatment assignments. The goal is to find out if adding these drugs to TACE can improve outcomes for patients with localized liver cancer that cannot be treated with surgery or other curative methods.

Eligibility Criteria

Inclusion Criteria

  • No signs of cancer outside the liver.
  • Cancer cannot be treated with surgery, transplantation, or ablation, but can be treated with TACE.
  • Child Pugh score class A, indicating good liver function.
  • ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Cancer that can be measured using specific criteria.
  • Adequate organ and bone marrow function.

Exclusion Criteria

  • History of heart failure, unstable chest pain, or uncontrolled heart rhythm problems.
  • History of liver-related brain condition (hepatic encephalopathy).
  • Major blockage in the portal vein seen on initial imaging.
  • Uncontrolled high blood pressure.
  • Co-infection with hepatitis B and hepatitis D viruses.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.