The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With HAIC for HCC: a Retrospective Study

December 8, 2025 updated by: Shi Ming, Sun Yat-sen University

The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With Hepatic Arterial Infusion Chemotherapy of FOLFOX for HCC: a Retrospective Study

This is a multicenter，retrospective study to explore the effectiveness and safety of Atezo/Bev plus hepatic artery infusion chemotherapy (HAIC) among adult patients with high-risk HCC in real-world clinical practice in China. Eligible patients diagnosed with high-risk HCC initiating the study treatment of interest between 28 October 2020 and 31 June 2025 will be included in this study. Secondary data from medical records of approximately 10 sites across China will be utilized.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-Sen University Cancer Center

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Aged ≥ 18 years at the initiation of Atezo/Bev plus HAIC
  • Initiating Atezo/Bev between 28 October 2020 and 31 June 2025

  • Diagnosed with high-risk HCC as evidenced clinically or by radiology, histology or cytology before or at the initiation of Atezo/Bev plus HAIC. The evidence of being diagnosed as "high-risk" was based on the IMbrave 150, including any of the following:

    • tumor invasion of the main trunk or contralateral branch of the portal vein (Vp4)
    • bile duct invasion
    • tumor occupancy of 50% or more of the liver
  • At least one visit record after the initiation of Atezo/Bev plus HAIC

Exclusion criteria:

  • Diagnosed with concomitant cancer except for basal cell carcinoma before or at the initiation of Atezo/Bev plus HAIC
  • Participating in interventional clinical studies before or at initiating Atezo/Bev plus HAIC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FOLFOX+TA
FOLOFOX-HAIC plus Atezolizumab and Bevacizumab
Drug: Atezolizumab & Bevacizumab
Atezolizumab 1200mg & Bevacizumab 15mg/kg Q3W
Procedure: FOLFOX-HAIC
hepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
overall survival (OS)
Time Frame: 6 months
defined as time from index date to death from any cause.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Real-world progression-free survival (rwPFS)
Time Frame: 6 months
defined as time from index date to the earlier of clinician-anchored progressive disease (may include but are not limited to local tumor progression, disease recurrence, new metastasis, or clinical progression anchored by clinicians) or death from any cause.
6 months
Time to discontinuation (TTD)
Time Frame: 6 months
defined as time from the initiation to discontinuation of Atezo/Bev plus HAIC.
6 months
Time to next treatment (TTNT)
Time Frame: 6 months
defined as time from the initiation of Atezo/Bev plus HAIC to the initiation of next systemic treatment.
6 months
Serum alpha-fetoprotein (AFP) reduction
Time Frame: 6 months
defined as > 50% reduction in AFP level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC.
6 months
Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction
Time Frame: 6 months
defined as > 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC.
6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame: 30 days
Safety
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 10, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HAIC+TA Retrospective

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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