Active not recruitingOBSERVATIONAL

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

This study aims to understand the best treatment path for adults with a type of liver cancer called unresectable hepatocellular carcinoma (uHCC), which means surgery isn't an option. Previously, certain drugs were used as a first choice, but new immune-boosting treatments like atezolizumab and bevacizumab have shown great promise as the first step. Since these newer treatments have changed how liver cancer is managed, doctors now need to figure out the best order for other treatments that follow. This study will collect information from existing medical records to see how long people live and how well their cancer responds to different treatments after they've had the new immune-boosting combinations. It's an observational study, meaning you won't take new medicines or have extra tests.

At a glance

Status

Active not recruiting

Sponsor

Bayer

Enrolment target

300

Start

27 Nov 2023

Estimated completion

10 Dec 2026

Unresectable Hepatocellular Carcinoma

What is this study about?

This study is about learning more about a specific type of liver cancer called unresectable hepatocellular carcinoma (it's often shortened to uHCC). "Unresectable" simply means that the cancer can't be removed by surgery. For a long time, there were only a few main treatments available for this condition.

Recently, a new type of treatment called an "immuno-oncology combo" (like atezolizumab with bevacizumab) has become a preferred first choice. These treatments work by helping your body's own immune system fight the cancer cells. They've made a big difference in how long people with uHCC live. However, because these new treatments are quite effective, doctors now need to understand what the best next steps are. If someone has already had one of these new immune treatments, what's the best treatment to try next, and in what order? This study wants to find that out.

To do this, researchers will look at health information that is already collected during your routine medical care. They will observe what treatments you receive after the initial immune-boosting therapy and how well those treatments work. This includes things like how long you live, how long it takes for the cancer to potentially grow, and whether the cancer shrinks. By gathering this information from many people, doctors hope to gain a much clearer picture of the best future treatment plans for others with uHCC.

Key takeaways

The study is about liver cancer that can't be treated with surgery.
It helps doctors understand the best next treatments after initial immune-boosting therapies.
Information is collected from your existing medical records, not new tests.
Participation involves no new medicines or extra doctor visits.
Your involvement helps improve future care for liver cancer patients.
You must have already received a specific type of immune-boosting first-line treatment.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. You must have received a confirmed diagnosis of liver cancer that can't be removed by surgery (unresectable hepatocellular carcinoma).

Crucially, you should have already received a specific first-line treatment for your liver cancer. This would be an 'immuno-oncology combination' treatment, such as 'atezolizumab with bevacizumab,' or another similar combination approved by doctors.

Your doctor must have already decided to start you on a new treatment after this initial immune-boosting therapy as part of your usual care. You also can't be taking part in any other research study that involves treatments or tests beyond what you would normally receive.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult (18 years or older)?
Do you have liver cancer that doctors say cannot be removed by surgery?
Have you already received a 'first-line' immune-boosting treatment like atezolizumab and bevacizumab (or a similar combination)?
Has your doctor already decided to start you on a new treatment after that first immune therapy?
Are you not currently in another research study that involves new treatments or tests?

Answer every question to see your result.

What does participation involve?

Taking part in this study is very straightforward because it's an "observational" study. This means researchers will simply collect information from your existing medical records and possibly talk to you during your regular doctor's visits. You won't be asked to change any of your treatments, take new medications that aren't part of your usual care, or have any extra tests or appointments specifically for the study. The study will look at your health information from September 2023 to December 2026, covering a period of about 3 years. You will be observed from the time you start your new treatment after the initial immune-boosting therapy until the end of your participation in the study.

Potential risks and benefits

Since this study only involves collecting information from your existing medical records and routine care, there are no direct medical risks from participating. You won't be taking any new medicines or undergoing extra procedures. The main benefit is that your health information, combined with that of others, will help doctors learn more about the best ways to treat liver cancer after initial immune-boosting therapies. This could improve care for future patients. You have the right to withdraw your consent at any time, which means researchers would stop collecting your information for the study.

Locations (17)

Mercy Medical Center - Medline Healthcare Services LLC
Verified postcode
Baltimore, United States
University of Michigan Health System
Verified postcode
Ann Arbor, United States
Roswell Park Comprehensive Cancer Center
Verified postcode
Buffalo, United States
University Of Cincinnati Division Of Hematology Oncology - UC Health System
Verified postcode
Cincinnati, United States
Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center
Verified postcode
Philadelphia, United States
Einstein Medical Center
Verified postcode
Philadelphia, United States
Many Locations
Unverified
Multiple Locations, Argentina
Many Locations
Unverified
Multiple Locations, Brazil
Many Locations
Unverified
Multiple Locations, China
Many Locations
Unverified
Multiple Locations, Colombia
Many Locations
Unverified
Multiple Locations, France
Many Locations
Unverified
Multiple Locations, Greece

Common questions

What is 'unresectable' liver cancer?

This simply means the liver cancer cannot be removed through surgery.

What does 'immuno-oncology combination' treatment mean?

It's a type of treatment that helps your body's own immune system fight the cancer cells more effectively.

Will I have to take new medicines for this study?

No, you will not. This study only collects information about the treatments you are already receiving as part of your usual medical care.

Will I need extra doctor's appointments?

No, you won't need any additional appointments beyond your usual routine medical visits.

Why is this study important?

It will help doctors understand the best order of treatments for liver cancer after new immune-boosting therapies, which could improve care for many patients.