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Completed

NCT Number: NCT07272265

The Effectiveness and Safety in High-risk Patients Receiving First-line Atezolizumab and Bevacizumab Combined With HAIC 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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Atezolizumab & Bevacizumab

Drug

Atezolizumab 1200mg & Bevacizumab 15mg/kg Q3W

FOLFOX-HAIC

Procedure

hepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil

Primary outcomes

  1. overall survival (OS)

    Time frame: 6 months

    defined as time from index date to death from any cause.

Secondary outcomes

  1. 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.

  2. Time to discontinuation (TTD)

    Time frame: 6 months

    defined as time from the initiation to discontinuation of Atezo/Bev plus HAIC.

  3. 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.

  4. 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.

  5. 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. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: 30 days

    Safety

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2025
Registry last updated
Dec 9, 2025

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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