Study on Tremelimumab and Durvalumab for Advanced Liver Cancer with Child-Pugh-B Cirrhosis

Sponsor: The University of Texas Health Science Center at San Antonio

Sponsor score: 40

ClinicalTrials ID:NCT06526104

Provider View

This clinical trial is testing a combination of two drugs, Tremelimumab and Durvalumab, to see if they are safe and effective for patients with advanced liver cancer and a specific type of liver cirrhosis called Child-Pugh-B. The study focuses on patients who often have more severe disease and are from underserved communities.

Patient Parameters

Program Overview

This study is for patients with advanced liver cancer, known as hepatocellular carcinoma (HCC), who have not received prior treatment. It aims to test the safety and effectiveness of a drug combination called T300+D, which includes Tremelimumab and Durvalumab. The study is particularly important for understanding how these drugs work in patients from diverse backgrounds, including racial and ethnic minorities, who are often underrepresented in clinical trials.

Description

Participants in this study will receive a one-time dose of Tremelimumab (300 mg) and regular doses of Durvalumab (1500 mg) every four weeks. The treatment will continue until the cancer progresses, side effects become too severe, or the patient decides to stop. Before starting the treatment, patients will have a CT or MRI scan to assess their cancer. Follow-up scans will be done every two months to monitor the cancer's response to the treatment. Patients will be followed for up to one year to track their survival and any side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with advanced liver cancer (HCC) that cannot be treated with local therapies.
  • Have a specific type of liver cirrhosis called Child-Pugh-B7 or B8.
  • Be in good general health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • If infected with Hepatitis B, must be on antiviral therapy with a low viral load. No antiviral therapy is required for Hepatitis C.
  • Have adequate organ and bone marrow function, as shown by specific blood test results.
  • Weigh more than 30 kg (about 66 pounds).
  • Be able to understand and sign a consent form.
  • Be 18 years or older.
  • Willing to follow the study protocol, including attending all visits and undergoing all tests.
  • Have a life expectancy of at least 12 weeks.
  • Have at least one measurable tumor that has not been treated with radiation.

Exclusion Criteria

  • Eligible for treatments that could cure the cancer.
  • Have had uncontrolled liver-related brain issues in the past six months.
  • Have active substance or alcohol abuse that could interfere with the study.
  • Have another cancer that could affect the study results.
  • Have had prior treatment for advanced liver cancer.
  • Participating in another clinical trial or have done so in the past month.
  • Receiving other cancer treatments.
  • Have had major surgery within the past 28 days.
  • Have had an organ transplant.
  • Have certain autoimmune or inflammatory diseases, unless well-controlled.
  • Have uncontrolled illnesses or infections.
  • Have a history of certain brain or immune system conditions.
  • Have used immunosuppressive medication recently, with some exceptions.
  • Have received a live vaccine recently.
  • Are pregnant, breastfeeding, or not using effective birth control.
  • Have allergies to the study drugs.
  • Have participated in previous studies with these drugs.

Locations

FACILITYZIPCITYSTATE
UT Health San Antonio78229San AntonioTexas

Get This Program In Your Inbox

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