Study on Durvalumab and Tremelimumab as First Treatment for Advanced Liver Cancer

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05883644

Provider View

This clinical trial is testing the safety and effectiveness of a new treatment using Durvalumab and Tremelimumab as the first therapy for patients with advanced liver cancer that cannot be removed by surgery.

Patient Parameters

Program Overview

The purpose of this study is to evaluate if a combination of two drugs, Durvalumab and Tremelimumab, can be a safe and effective first treatment for patients with advanced liver cancer (HCC) that cannot be surgically removed. The study will involve several stages, including initial screening, treatment, and follow-up to monitor safety and survival.

Description

This study is a Phase IIIb trial, meaning it is in an advanced stage of testing. It is open-label, so both doctors and participants know what treatment is being given. The study is being conducted at multiple locations and involves a single group of participants receiving the same treatment. The treatment being tested is called STRIDE, which includes regular doses of Tremelimumab and Durvalumab.

Participants must have advanced liver cancer that cannot be removed by surgery and meet specific health criteria. They should not have received any previous systemic treatment for liver cancer, although they may have had other local treatments in the past. These local treatments must have been completed at least four weeks before starting the study treatment.

The study consists of four main periods: a screening phase to determine eligibility, a treatment phase where participants receive the study drugs, a safety follow-up to monitor any side effects, and a survival follow-up to track long-term outcomes.

Eligibility Criteria

Inclusion Criteria

  • Have advanced liver cancer that cannot be removed by surgery, confirmed by medical tests.
  • Have not received any previous systemic treatment for liver cancer.
  • Expected to live for at least 12 weeks.
  • Have at least one measurable tumor that can be accurately tracked using scans.
  • Not eligible for other local treatments for liver cancer.
  • Meet specific health criteria related to liver function and overall health status.
  • If infected with hepatitis B or C, must be receiving appropriate antiviral treatment.
  • Have adequate organ and bone marrow function as shown by blood tests.
  • Women of childbearing potential must have a negative pregnancy test and use effective birth control.
  • Both male and female participants must agree to use contraception during the study.
  • Weigh more than 30 kg (about 66 pounds).

Exclusion Criteria

  • Have any uncontrolled or serious diseases that could interfere with the study.
  • Have a history of severe heart problems or other significant health issues.
  • Have another type of cancer, unless it was treated successfully and is not expected to return.
  • Have ongoing side effects from previous cancer treatments.
  • Have autoimmune or inflammatory disorders.
  • Have a history of brain or spinal cord cancer spread.
  • Have certain types of liver cancer or other liver conditions.
  • Have active infections like HIV or tuberculosis.
  • Have taken certain medications that could interfere with the study drugs.
  • Have had major surgery or a significant injury recently.

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