Hepatocellular Carcinoma (HCC)
Conditions
Keywords
FOLFOX-HAIC, Atezolizumab, Bevacizumab, high-risk HCC
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.
Interventions
Atezolizumab 1200mg & Bevacizumab 15mg/kg Q3W
PROCEDUREFOLFOX-HAIC
hepatic artery infusion chemotherapy of oxaliplatin, leucovorin, and fluorouracil
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall survival (OS) | 6 months | defined as time from index date to death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to discontinuation (TTD) | 6 months | defined as time from the initiation to discontinuation of Atezo/Bev plus HAIC. |
| Time to next treatment (TTNT) | 6 months | defined as time from the initiation of Atezo/Bev plus HAIC to the initiation of next systemic treatment. |
| Real-world progression-free survival (rwPFS) | 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. |
| Prothrombin induced by the absence of vitamin K or antagonist- II (PIVKA-II) reduction | 6 months | defined as \> 50% reduction in PIVKA-II level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC. |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 30 days | Safety |
| Serum alpha-fetoprotein (AFP) reduction | 6 months | defined as \> 50% reduction in AFP level after 3 months (± 4 weeks) of the initiation of Atezo/Bev plus HAIC. |
Countries
China
Outcome results
None listed