Trial Condition(s):

Unresectable hepatocellular carcinoma

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 (REFINE-IO)

Bayer Identifier:

22453

ClinicalTrials.gov Identifier:

NCT06117891

EudraCT Number:

Not Available

EU CT Number:

Not Available

Recruiting

Trial Purpose

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.

Inclusion Criteria
- Adult patients, ≥ 18 years of age on the day of signing informed consent.
- Confirmed diagnosis of uHCC, treated in a first-line setting with AB or another approved 1L-IO combo therapy.
- Decision to initiate treatment with a second-line systemic treatment was made as per investigator’s routine treatment practice prior to study enrollment.
- Signed informed consent or (for patients under legal age) signed informed assent by the patient (where applicable) and signed informed consent by parents / legal guardian.
- No participation in an investigational program with interventions outside of routine clinical practice.
Exclusion Criteria
- Not applicable

Trial Summary

Enrollment Goal
300
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Unspecified
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Argentina

Status
Recruiting
Locations

Many Locations

Many Locations, Brazil

Status
Not yet recruiting
Locations

Many Locations

Many Locations, China

Status
Recruiting
Locations

Many Locations

Many Locations, Colombia

Status
Recruiting
Locations

Many Locations

Many Locations, Spain

Status
Recruiting
Locations

Many Locations

Many Locations, France

Status
Recruiting
Locations

Many Locations

Many Locations, Greece

Status
Recruiting
Locations

Many Locations

Many Locations, Italy

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Saudi Arabia

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Thailand

Status
Recruiting
Locations

Many Locations

Many Locations, Taiwan, China

Status
Recruiting
Locations

Mercy Medical Center - Medline Healthcare Services LLC

Baltimore, United States, 21202

Status
Not yet recruiting
Locations

Many Locations

Many Locations, Unmapped

Status
Recruiting
Locations

University of Michigan Health System

Ann Arbor, United States, 48109

Status
Not yet recruiting
Locations

Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center

Philadelphia, United States, 19104

Status
Not yet recruiting
Locations

Einstein Medical Center

Philadelphia, United States, 19141

Status
Not yet recruiting
Locations

Roswell Park Comprehensive Cancer Center

Buffalo, United States, 14203

Status
Not yet recruiting
Locations

University Of Cincinnati Division Of Hematology Oncology - UC Health System

Cincinnati, United States, 45219

Status
Not yet recruiting

Trial Design