Clinical trial NCT06117891: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Unresectable Hepatocellular Carcinoma
Keywords: uHCC
systemic treatment
real-world data
prospective
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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 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

Primary outcomes:
measure: Overall survival (OS)
timeFrame: Approximately 36 months
Secondary outcomes:
measure: Discriptive analysis of demographic characteristics
timeFrame: At baseline before the first drug administration of second-line systemic treatment
measure: Discriptive analysis of clinical characteristics
timeFrame: At baseline before the first drug administration of second-line systemic treatment
measure: Duration of therapy (DoT)
timeFrame: Approximately 36 months
measure: Progression-free survival (PFS)
timeFrame: Approximately 36 months
measure: Best overall response rate (ORR)
timeFrame: Approximately 36 months
measure: Treatment sequences post first-line AB or other IO combinations
timeFrame: Approximately 36 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Mercy Medical Center - Medline Healthcare Services LLC
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: Cincinnati
country: United States
facility: University Of Cincinnati Division Of Hematology Oncology - UC Health System
state: Ohio
city: Philadelphia
country: United States
facility: Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Einstein Medical Center
state: Pennsylvania
city: Multiple Locations
country: Argentina
facility: Many Locations
city: Multiple Locations
country: Brazil
facility: Many Locations
city: Multiple Locations
country: China
facility: Many Locations
city: Multiple Locations
country: Colombia
facility: Many Locations
city: Multiple Locations
country: France
facility: Many Locations
city: Multiple Locations
country: Greece
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Korea, Republic of
facility: Many Locations
city: Multiple Locations
country: Mexico
facility: Many Locations
city: Multiple Locations
country: Saudi Arabia
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
city: Multiple Locations
country: Thailand
facility: Many Locations
city: Multiple Locations
country: Turkey
facility: Many Locations
Study officials:
References: