RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-11-27
Study Completion:2027-02-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06117891

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients, ≥ 18 years of age on the day of signing informed consent.
  2. * Confirmed diagnosis of uHCC, treated in a first-line setting with AB or another approved 1L-IO combo therapy.
  3. * Decision to initiate treatment with a second-line systemic treatment was made as per investigator's routine treatment practice prior to study enrollment.
  4. * 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.
  5. * No participation in an investigational program with interventions outside of routine clinical practice.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Bayer Clinical Trials Contact
CONTACT
(+)1-888-84 22937
clinical-trials-contact@bayer.com

Study Locations (Sites)

Mercy Medical Center - Medline Healthcare Services LLC
Baltimore, Maryland, 21202
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14203
United States
University Of Cincinnati Division Of Hematology Oncology - UC Health System
Cincinnati, Ohio, 45219
United States
Corporal Michael J Crescenz Department Of Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104
United States
Einstein Medical Center
Philadelphia, Pennsylvania, 19141
United States

Collaborators and Investigators

Sponsor: Bayer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-27
Study Completion Date2027-02-01

Study Record Updates

Study Start Date2023-11-27
Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

  • uHCC
  • systemic treatment
  • real-world data
  • prospective

Additional Relevant MeSH Terms

  • Unresectable Hepatocellular Carcinoma