Study Comparing Chemotherapy and Atezolizumab with or without Bevacizumab for Advanced Liver Cancer

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT05211323

This clinical trial is exploring whether adding the drug bevacizumab to a combination of chemotherapy and the immunotherapy drug atezolizumab can improve treatment outcomes for patients with advanced liver cancer that cannot be surgically removed.

Patient Parameters

Program Overview

This study is testing two different treatment combinations for advanced liver cancer that cannot be removed by surgery. One group will receive chemotherapy drugs (gemcitabine and cisplatin) along with the immunotherapy drug atezolizumab. The other group will receive the same chemotherapy and immunotherapy drugs, plus an additional drug called bevacizumab. Atezolizumab helps the immune system attack cancer cells, while bevacizumab works by stopping the growth of blood vessels that supply the tumor, potentially slowing its growth. The study aims to find out if the addition of bevacizumab can help control the cancer better than the standard treatment.

Description

The main goal of this study is to see if adding bevacizumab to a combination of chemotherapy and immunotherapy can help patients with advanced liver cancer live longer without the disease getting worse. The study will also look at how well the cancer responds to the treatment and how long patients live overall.

Participants will be randomly assigned to one of two groups:

  • Group A: Will receive atezolizumab and bevacizumab along with chemotherapy drugs gemcitabine and cisplatin. These medications will be given through an IV on specific days in a 21-day cycle, which will repeat as long as the treatment is effective and side effects are manageable.

  • Group B: Will receive atezolizumab with the same chemotherapy drugs, gemcitabine and cisplatin, but without bevacizumab. This group will also follow a 21-day cycle.

Throughout the study, participants will have regular scans (CT or MRI) and blood tests to monitor their health and the cancer's response to treatment. After completing the study treatment, participants will be followed up for three years to track their progress.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of a specific type of liver cancer called combined hepatocellular carcinoma-cholangiocarcinoma (cHCC-CC).
  • Cancer must be advanced and cannot be removed by surgery.
  • Must not have received previous treatment for advanced cHCC-CC, except for certain chemotherapy if it was completed over 6 months ago.
  • Must have good liver function (Child Pugh class A).
  • Must not be pregnant or breastfeeding and must agree to use effective contraception during and after the study.
  • Must be able to understand and sign a consent form.
  • Must have adequate blood counts and organ function as shown by recent lab tests.
  • Must not have active brain metastases or certain infections like active hepatitis B or C.
  • Must not have a history of severe heart disease or autoimmune diseases, with some exceptions.
  • Must not have received certain treatments like immune checkpoint inhibitors or live vaccines recently.

Locations

FACILITYZIPCITYSTATE
Sutter Auburn Faith Hospital95602AuburnCalifornia
Alta Bates Summit Medical Center-Herrick Campus94704BerkeleyCalifornia
Palo Alto Medical Foundation-Fremont94538FremontCalifornia
Memorial Medical Center95355ModestoCalifornia
Palo Alto Medical Foundation-Camino Division94040Mountain ViewCalifornia
Palo Alto Medical Foundation Health Care94301Palo AltoCalifornia
Sutter Roseville Medical Center95661RosevilleCalifornia
Sutter Medical Center Sacramento95816SacramentoCalifornia
California Pacific Medical Center-Pacific Campus94115San FranciscoCalifornia
Palo Alto Medical Foundation-Santa Cruz95065Santa CruzCalifornia

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