Study on Atezolizumab and Bevacizumab Before Surgery for Treating Removable Liver Cancer

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT04721132

Provider View

This clinical trial is exploring whether using the drugs atezolizumab and bevacizumab before surgery can help treat liver cancer that can be surgically removed. These drugs may help the immune system attack cancer and prevent it from growing and spreading.

Patient Parameters

Program Overview

This phase II study is testing the effects of two drugs, atezolizumab and bevacizumab, given before surgery to treat liver cancer that can be removed. Atezolizumab is an immunotherapy drug that may help the immune system fight cancer, while bevacizumab may stop cancer cells from growing. The goal is to see if this combination can prevent liver cancer from coming back after surgery.

Description

Primary Objectives:

  1. To check the safety and how well patients tolerate the combination of atezolizumab and bevacizumab before surgery.
  2. To see if this treatment can completely eliminate cancer in some patients.

Secondary Objective:

  • To study the relationship between complete cancer response, overall response at surgery, how long the response lasts, and overall survival.

Exploratory Objectives:

  1. To look at changes in liver tissue over time.
  2. To measure changes in immune cells and other markers in the body.
  3. To explore how certain proteins and genes relate to treatment effectiveness.
  4. To evaluate changes in specific immune and liver markers as indicators of treatment response.
  5. To assess the impact of treatment on the variety of immune cells targeting the tumor.
  6. To explore the relationship between immune and molecular changes in tumor tissues and blood with treatment outcomes.

Treatment Plan:

  • Patients will receive atezolizumab and bevacizumab through an IV on the first day of each cycle.
  • Treatment cycles repeat every 21 days for up to 3 cycles unless the disease progresses or side effects are unacceptable.
  • Surgery will be performed around week 12.
  • After treatment, patients will have follow-up visits every 3 months for 2 years.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent to participate.
  • Age 18 or older.
  • Diagnosed with liver cancer that can be surgically removed.
  • No cancer spread outside the liver.
  • Must have a specific liver function score (Child-Turcotte-Pugh score of A).
  • Must have at least one measurable tumor.
  • Must have treated or no esophageal varices.
  • Willing to provide a tumor sample for research.
  • Good overall health with a performance status of 0-1.
  • Adequate blood and organ function based on specific tests.
  • Negative HIV test.
  • Controlled hepatitis B or C if present.
  • Women and men must agree to use effective birth control during and after the study.
  • Women must not be pregnant or breastfeeding.

Exclusion Criteria

  • Have been treated for this or another cancer recently.
  • Have certain types of liver cancer or other cancers.
  • Have untreated esophageal or stomach varices.
  • Have a history of certain serious medical conditions like fistulas or abscesses.
  • Have a history of blood clots or bleeding disorders.
  • Use certain medications like high-dose aspirin or anticoagulants.
  • Have had recent serious infections or surgeries.
  • Have severe heart or lung disease.
  • Have uncontrolled high blood pressure.
  • Have a history of severe allergic reactions to similar drugs.
  • Have received investigational drugs recently.
  • Have autoimmune diseases or immune deficiencies.
  • Have had organ transplants.
  • Are pregnant or breastfeeding, or plan to become pregnant during the study.

Locations

FACILITYZIPCITYSTATE
Houston Methodist Hospital77030HoustonTexas
M D Anderson Cancer Center77030HoustonTexas

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