Comparing Localized and Systemic Treatments for Patients with Intermediate-Stage Liver Cancer (HCC)

Sponsor: University of Texas Southwestern Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05537402

Provider View

This study aims to compare the effectiveness and safety of two standard treatments for patients with intermediate-stage liver cancer (HCC). It will evaluate the use of atezolizumab and bevacizumab against localized treatments like TACE or TARE.

Patient Parameters

Program Overview

The purpose of this study is to compare two treatment approaches for patients with intermediate-stage liver cancer (HCC). One approach uses the drugs atezolizumab and bevacizumab, while the other uses localized treatments such as transarterial chemoembolization (TACE) or transarterial radioembolization (TARE). The main goal is to see which treatment is more effective in preventing the cancer from getting worse. Researchers will also look at the safety of these treatments and analyze the results to understand any differences between the two groups.

Description

This study is designed to evaluate the effectiveness and safety of two different treatment methods for patients with intermediate-stage liver cancer (HCC). The first method involves using the drugs atezolizumab and bevacizumab, which are given through the bloodstream to target cancer cells throughout the body. The second method involves localized treatments, either transarterial chemoembolization (TACE) or transarterial radioembolization (TARE), which target the cancer directly in the liver.

The primary focus of the study is to measure progression-free survival, which means the length of time during and after treatment that the cancer does not get worse. Researchers will compare the results between the two treatment groups using statistical methods to ensure accurate comparisons. They will also control for any other factors that might affect the outcomes.

Participants will be closely monitored throughout the study to assess the safety and effectiveness of the treatments. The study aims to provide valuable insights into which treatment approach offers better outcomes for patients with intermediate-stage liver cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with liver cancer (HCC) confirmed by imaging or biopsy.
  • Cancer is localized to the liver and has not been treated before.
  • Not eligible for surgery, liver transplant, or local ablation.
  • No cancer spread outside the liver or into blood vessels.
  • Child Pugh class A liver function.
  • Aged 18 years or older.
  • Good overall health with an ECOG performance status of 0 or 1.
  • If infected with hepatitis B, must be on antiviral therapy.
  • If infected with hepatitis C, must follow local treatment guidelines.
  • At least one liver tumor that can be measured on scans.
  • Adequate blood and organ function based on specific lab tests.
  • Recent upper endoscopy to check for varices.
  • Negative HIV test.
  • Agree to use effective birth control during and after the study.
  • Able to understand and sign informed consent.

Exclusion Criteria

  • Recent cancer treatments like chemotherapy or radiotherapy.
  • Previous immunotherapy for cancer.
  • Specific types of liver cancer like fibrolamellar or sarcomatoid HCC.
  • Cancer that has spread to blood vessels or other parts of the body.
  • Significant fluid buildup in the abdomen.
  • Recent history of liver-related brain issues.
  • Listed for liver transplant.
  • Recent bleeding from varices.
  • Blood clotting disorders.
  • Previous treatment with certain immune therapies.
  • Recent use of investigational drugs.
  • Active infections or other serious health conditions.
  • Recent use of certain medications like high-dose aspirin.
  • History of autoimmune diseases or immune deficiencies.
  • Recent major surgery or injury.
  • Uncontrolled high blood pressure.
  • History of other serious health conditions like heart disease.
  • Pregnant or breastfeeding women.
  • Recent use of live vaccines.
  • Allergies to study drugs or similar compounds.

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