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

NCT06117891 | Recruiting

• 1 other identifier: 22453
• Study Type: observational
• Target: 300
• Locations: 15 countries
• Sites: 20

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.

Conditions

Unresectable Hepatocellular Carcinoma

Keywords

uHCC; systemic treatment; real-world data; prospective

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 36 months

Secondary Outcomes (6)

• Discriptive analysis of demographic characteristics

  At baseline before the first drug administration of second-line systemic treatment

• Discriptive analysis of clinical characteristics

  At baseline before the first drug administration of second-line systemic treatment

• Duration of therapy (DoT)

  Approximately 36 months

• Progression-free survival (PFS)

  Approximately 36 months

• Best overall response rate (ORR)

  Approximately 36 months

Study Arms (1)

Treatment

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 at the time of study enrollment

Drug: Atezolizumab; Drug: Bevacizumab; Drug: Durvalumab; Drug: Tremelimumab,

Interventions

Bevacizumab DRUG

Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.

Treatment

Atezolizumab DRUG

Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.

Treatment

Durvalumab DRUG

Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors combination.

Treatment

Tremelimumab, DRUG

Durvalumab combined with Tremelimumab, another immuno-oncology (IO) checkpoint inhibitors combination.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Not applicable

Sponsors & Collaborators

• Bayer: lead

Study Sites (20)

Mercy Medical Center - Medline Healthcare Services LLC

Baltimore, Maryland, 21202, United States

NOT YET RECRUITING

University of Michigan Health System

Ann Arbor, Michigan, 48109, United States

NOT YET RECRUITING

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14203, United States

NOT YET RECRUITING

University Of Cincinnati Division Of Hematology Oncology - UC Health System

Cincinnati, Ohio, 45219, United States

NOT YET RECRUITING

Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center

Philadelphia, Pennsylvania, 19104, United States

NOT YET RECRUITING

Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

NOT YET RECRUITING

Many Locations

Multiple Locations, Argentina

RECRUITING

Many Locations

Multiple Locations, Brazil

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, China

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Colombia

RECRUITING

Many Locations

Multiple Locations, France

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Greece

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Italy

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Mexico

WITHDRAWN

Many Locations

Multiple Locations, Saudi Arabia

WITHDRAWN

Many Locations

Multiple Locations, South Korea

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Spain

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Taiwan

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Thailand

ACTIVE NOT RECRUITING

Many Locations

Multiple Locations, Turkey (Türkiye)

WITHDRAWN

MeSH Terms

Interventions

atezolizumab; Bevacizumab; durvalumab; tremelimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Bayer Clinical Trials Contact

CONTACT

(+)1-888-84 22937; clinical-trials-contact@bayer.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: November 27, 2023
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1); TW (1); US (6); BR (1); AR (1); ES (1); KR (1); TH (1); CN (1); ME (1); FR (1); IT (1); CO (1); SA (1); TU (1)