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

NCT07272265 | Completed DMC

• 1 other identifier: HAIC+TA Retrospective
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

FOLFOX-HAIC; Atezolizumab; Bevacizumab; high-risk HCC

Outcome Measures

Primary Outcomes (1)

• overall survival (OS)

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

  6 months

Secondary Outcomes (6)

• Real-world progression-free survival (rwPFS)

  6 months

• Time to discontinuation (TTD)

  6 months

• Time to next treatment (TTNT)

  6 months

• Serum alpha-fetoprotein (AFP) reduction

  6 months

• Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction

  6 months

Study Arms (1)

FOLFOX+TA

EXPERIMENTAL

FOLOFOX-HAIC plus Atezolizumab and Bevacizumab

Drug: Atezolizumab & Bevacizumab; Procedure: FOLFOX-HAIC

Interventions

Atezolizumab & Bevacizumab DRUG

Atezolizumab 1200mg \& Bevacizumab 15mg/kg Q3W

FOLFOX+TA

FOLFOX-HAIC PROCEDURE

hepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil

FOLFOX+TA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

atezolizumab; Bevacizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: October 28, 2020
• Primary Completion: May 31, 2025
• Study Completion: November 10, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

CN (1)