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

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: Completed
• Conditions: Hepatocellular Carcinoma (HCC)
• Intervention / Treatment: Drug: Atezolizumab & Bevacizumab; Procedure: FOLFOX-HAIC

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Sun yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
overall survival (OS)	defined as time from index date to death from any cause.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Real-world progression-free survival (rwPFS)	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)	defined as time from the initiation to discontinuation of Atezo/Bev plus HAIC.	6 months
Time to next treatment (TTNT)	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	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	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	Safety	30 days

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2020
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): November 10, 2025

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: December 8, 2025
• First Posted (Estimated): December 9, 2025

Study Record Updates

• Last Update Posted (Estimated): December 9, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Bevacizumab; Atezolizumab; FOLFOX-HAIC; high-risk HCC
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; atezolizumab
• Other Study ID 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