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

Sun Yat-sen University logo

Sun Yat-sen University

Status

Completed

Conditions

Hepatocellular Carcinoma (HCC)

Treatments

Drug: Atezolizumab & Bevacizumab
Procedure: FOLFOX-HAIC

Study type

Interventional

Funder types

Other

Identifiers

NCT07272265
HAIC+TA Retrospective

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

300 participants in 1 patient group

FOLFOX+TA
Experimental group
Description:
FOLOFOX-HAIC plus Atezolizumab and Bevacizumab
Treatment:
Procedure: FOLFOX-HAIC
Drug: Atezolizumab & Bevacizumab

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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