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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Unresectable Hepatocellular Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atezolizumab

Drug

Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.

Bevacizumab

Drug

Atezolizumab combined with Bevacizumab, immune checkpoint inhibitors combination.

Durvalumab

Drug

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

Tremelimumab,

Drug

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

Primary outcomes

  1. Overall survival (OS)

    Time frame: Approximately 36 months

    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.

Secondary outcomes

  1. Discriptive analysis of demographic characteristics

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

  2. Discriptive analysis of clinical characteristics

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

  3. Duration of therapy (DoT)

    Time frame: Approximately 36 months

    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.

  4. Progression-free survival (PFS)

    Time frame: Approximately 36 months

    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.

  5. Best overall response rate (ORR)

    Time frame: Approximately 36 months

    ORR will be defined according to investigator-assessed data according to local standard.

  6. Treatment sequences post first-line AB or other IO combinations

    Time frame: Approximately 36 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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

Acronym: REFINE-IO

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 7, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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