RecruitingNCT06117891

An Observational Study to Learn More About How Well a Treatment Works When Given After Treatment With Atezolizumab and Bevacizumab or Another Similar Combination of Drugs in Adults With Liver Cancer That Cannot be Treated With Surgery

An Observational Study in Patients With Unresectable Hepatocellular Carcinoma (uHCC) Following Treatment With Atezolizumab Plus Bevacizumab (AB) or With Another Approved Immuno-oncology Immune Checkpoint Inhibitor Combination in First-line


Sponsor

Bayer

Enrollment

300 participants

Start Date

Nov 27, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

This is an observational study in which only data will be collected from adults with unresectable hepatocellular carcinoma. These adults should be prescribed a different treatment after treatment with atezolizumab and bevacizumab, or another similar combination of drugs, by their doctors. Unresectable hepatocellular carcinoma (uHCC) is a type of liver cancer that cannot be treated with surgery. In the past, sorafenib was the only approved first-line anti-cancer drug for people with uHCC. Regorafenib and other drugs were approved as second-line treatments for uHCC if a person could not take sorafenib or it stopped working for them. Lately, another first-line (1L) treatment called immuno-oncology (IO) immune checkpoint inhibitor combination (1L-IO combo), like atezolizumab with bevacizumab (AB), has become the preferred choice of treatment. This is because of the meaningful impact on patient survival. 1L-IO combo are drugs that help the body's defense system recognize and kill cancer cells. Since the other treatments were previously approved for use following sorafenib, the best order to take these treatments in following an 1L-IO combo is unknown. To better understand and determine this order, more knowledge is needed about how well different treatments work in participants with uHCC who have been treated with AB or another 1L-IO combo. The main purpose of this study is to learn more about how well different treatments work when given after first-line treatment with AB or another approved 1L-IO combo. To do this, researchers will collect data on how long the participants live (also called overall survival) from the start of any treatment given after the first-line treatment. In addition, researchers will also collect the following information to learn more about the participants who will be given a different treatment after the 1L-IO combo: * characteristics including age, sex, and race, and signs and symptoms of the participants over the duration of their first-line treatment * the length of time from the first to the last dose (also called duration of therapy) of the treatments given after the 1L-IO combo * the length of time until a participant's cancer worsens, or they die (also called progression free survival) from the start of the treatments given after the 1L-IO combo * the number of participants whose tumor completely disappears or shrinks (also called overall tumor response) after taking the treatments given after the 1L-IO combo * the sequence of treatments given after the 1L-IO combo Data will be collected from September 2023 to December 2026 and cover a period of around 3 years. The data will be collected using medical records or by interviewing the participants during their routine visits to the doctor. Researchers will observe participants from the start of the treatment given after the 1L-IO combo until the end of their participation in the study. In this study, only data from routine care will be collected. No visits or tests are required as part of this study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study tracks patients with advanced liver cancer (unresectable hepatocellular carcinoma, or uHCC) who have already been treated with a first-line immunotherapy combination (such as atezolizumab plus bevacizumab) and are now moving to a second-line treatment. Researchers want to understand real-world outcomes after first-line immunotherapy for liver cancer. **You may be eligible if:** - You are 18 or older - You have confirmed advanced liver cancer (uHCC) that cannot be treated with surgery - You were previously treated with atezolizumab/bevacizumab or a similar first-line immunotherapy combination - You are about to start a second-line systemic treatment based on your doctor's decision **You may NOT be eligible if:** - You have not received a first-line immunotherapy combination for liver cancer - You are currently participating in an interventional clinical trial - You are unable to provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAtezolizumab

Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.

DRUGBevacizumab

Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.

DRUGDurvalumab

Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors combination.

DRUGTremelimumab,

Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors combination.


Locations(20)

Mercy Medical Center - Medline Healthcare Services LLC

Baltimore, Maryland, United States

University of Michigan Health System

Ann Arbor, Michigan, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

University Of Cincinnati Division Of Hematology Oncology - UC Health System

Cincinnati, Ohio, United States

Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center

Philadelphia, Pennsylvania, United States

Einstein Medical Center

Philadelphia, Pennsylvania, United States

Many Locations

Multiple Locations, Argentina

Many Locations

Multiple Locations, Brazil

Many Locations

Multiple Locations, China

Many Locations

Multiple Locations, Colombia

Many Locations

Multiple Locations, France

Many Locations

Multiple Locations, Greece

Many Locations

Multiple Locations, Italy

Many Locations

Multiple Locations, Mexico

Many Locations

Multiple Locations, Saudi Arabia

Many Locations

Multiple Locations, South Korea

Many Locations

Multiple Locations, Spain

Many Locations

Multiple Locations, Taiwan

Many Locations

Multiple Locations, Thailand

Many Locations

Multiple Locations, Turkey (Türkiye)

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NCT06117891


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