Trial Title:
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
NCT ID:
NCT06117891
Condition:
Unresectable Hepatocellular Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Hepatocellular
Bevacizumab
Atezolizumab
Durvalumab
Tremelimumab
Conditions: Keywords:
uHCC
systemic treatment
real-world data
prospective
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Atezolizumab
Description:
Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Bevacizumab
Description:
Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Durvalumab
Description:
Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors
combination.
Arm group label:
Treatment
Intervention type:
Drug
Intervention name:
Tremelimumab,
Description:
Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors
combination.
Arm group label:
Treatment
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.
Criteria for eligibility:
Study pop:
Patients with a diagnosis of uHCC treated with first-line AB or another approved 1L-IO
combo and in whom a decision to treat with a second-line of systemic therapy has been
made by the treating physician. The investigator or a delegate at these centers collects
historic data (demographic and clinical characteristics) from medical records if
available. The investigator or a delegate collects treatment-related data during visits
that take place in routine practice.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mercy Medical Center - Medline Healthcare Services LLC
Address:
City:
Baltimore
Zip:
21202
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University of Michigan Health System
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Roswell Park Comprehensive Cancer Center
Address:
City:
Buffalo
Zip:
14203
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
University Of Cincinnati Division Of Hematology Oncology - UC Health System
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Einstein Medical Center
Address:
City:
Philadelphia
Zip:
19141
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Argentina
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Brazil
Status:
Not yet recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
China
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Colombia
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
France
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Greece
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Italy
Status:
Not yet recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Mexico
Status:
Withdrawn
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Saudi Arabia
Status:
Not yet recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Spain
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Thailand
Status:
Recruiting
Facility:
Name:
Many Locations
Address:
City:
Multiple Locations
Country:
Turkey
Status:
Withdrawn
Start date:
November 27, 2023
Completion date:
February 1, 2027
Lead sponsor:
Agency:
Bayer
Agency class:
Industry
Source:
Bayer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06117891
https://clinicaltrials.bayer.com/
