account_circleRecruiting
Unresectable hepatocellular carcinoma
Bayer Identifier:
22453
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
300Trial Dates
November 2023 - February 2027Phase
Phase 4Could I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many Locations | Many Locations, Argentina |
Recruiting | Many Locations | Many Locations, Brazil |
Recruiting | Many Locations | Many Locations, China |
Recruiting | Many Locations | Many Locations, Colombia |
Recruiting | Many Locations | Many Locations, Spain |
Recruiting | Many Locations | Many Locations, France |
Recruiting | Many Locations | Many Locations, Greece |
Recruiting | Many Locations | Many Locations, Italy |
Not yet recruiting | Many Locations | Many Locations, Saudi Arabia |
Recruiting | Many Locations | Many Locations, Thailand |
Withdrawn | Many Locations | Many Locations, Turkey |
Recruiting | Many Locations | Many Locations, Taiwan |
Not yet recruiting | Mercy Medical Center - Medline Healthcare Services LLC | Baltimore, 21202, United States |
Withdrawn | Many Locations | Many Locations, Mexico |
Recruiting | Many Locations | Many Locations, Korea,_republic_of |
Not yet recruiting | University of Michigan Health System | Ann Arbor, 48109, United States |
Not yet recruiting | Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center | Philadelphia, 19104, United States |
Not yet recruiting | Einstein Medical Center | Philadelphia, 19141, United States |
Not yet recruiting | Roswell Park Comprehensive Cancer Center | Buffalo, 14203, United States |
Not yet recruiting | University Of Cincinnati Division Of Hematology Oncology - UC Health System | Cincinnati, 45219, United States |
Primary Outcome
- Overall survival (OS)OS is defined as the time (days) from start of second-line systemic treatment to the date of death, due to any cause. Patients alive or lost to follow-up will be censored at their last date of follow-up.date_rangeTime Frame:Approximately 36 months
Secondary Outcome
- Discriptive analysis of demographic characteristicsdate_rangeTime Frame:At baseline before the first drug administration of second-line systemic treatment
- Discriptive analysis of clinical characteristicsdate_rangeTime Frame:At baseline before the first drug administration of second-line systemic treatment
- Duration of therapy (DoT)DoT in second-line setting will be calculated as the time (days) from the date of initiation of the second -line systemic treatment to the stop of this treatment regimen or to last date of follow-up, if treatment was ongoing on that date.date_rangeTime Frame:Approximately 36 months
- Progression-free survival (PFS)PFS is defined as the time (days) from the date of initiation of systemic treatment to the earliest date of first observed disease progression (radiological or clinical) or death due to any cause.date_rangeTime Frame:Approximately 36 months
- Best overall response rate (ORR)ORR will be defined according to investigator-assessed data according to local standard.date_rangeTime Frame:Approximately 36 months
- Treatment sequences post first-line AB or other IO combinationsdate_rangeTime Frame:Approximately 36 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A