Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Non-Resectable
Conditions
Keywords
yttrium 90, y-90, HCC, SIRT
Brief summary
Yttrium-90 (y90) Microsphere Injection Solution was approved by the NMPA in 2022. Currently, there is a lack of summary of real-world data in China. Therefore, this retrospective real-world study is intented to explore the characteristics and efficacy of HCC patients treated with y90 in China, aiming to provide reference for guiding and optimizing clinical practices and subsequent confirmatory clinical studies for the treatment of HCC patients in China.
Interventions
selective internal radiation therapy
Sponsors
GrandPharma (China) Co., Ltd.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. age ≥ 18 years old; 2. confirmed diagnosis of HCC 3. treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment
Exclusion criteria
no formal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best hepatic ORR measured by mRECIST criteria | 6 months following y90 therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR measured by mRECIST criteria | 6 months following y90 therapy | — |
| OS | From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months | — |
| TTP | From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months | time to progression |
| PFS | From date of first Y90 therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months | — |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | 6 months following y90 therapy | — |
Countries
China
Outcome results
None listed