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 University300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Hepatocellular Carcinoma (HCC)

Interventions

Atezolizumab & Bevacizumab

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

overall survival (OS)

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

Time frame: 6 months

Secondary Outcomes

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.

Time frame: 6 months

Time to discontinuation (TTD)

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

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 6 months

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

Safety

Time frame: 30 days

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes