Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Yttrium-90 (Y-90) resin microspheres.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma (HCC), Hepatocellular Carcinoma Non-Resectable. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Descriptive, Retrospective, Single-Arm Cohort Study on the Use of Selective Internal Radiation Therapy (SIRT) with Yttrium-90 Microspheres for Unresectable Primary Hepatocellular Carcinoma (HCC) in the Chinese Population
Overview
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
- Device Yttrium-90 (Y-90) resin microspheres
selective internal radiation therapy
Primary outcome measures
- best hepatic ORR measured by mRECIST criteria [Time frame: 6 months following y90 therapy]
Secondary outcome measures (5)
- ORR measured by mRECIST criteria [Time frame: 6 months following y90 therapy]
- OS [Time frame: From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months]
- TTP [Time frame: From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months]
- PFS [Time frame: 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 [Time frame: 6 months following y90 therapy]
Eligibility criteria
Inclusion criteria
- age ≥ 18 years old;
- confirmed diagnosis of HCC
- 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 exclusion criteria in a real-world study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 6 centers
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou
- The First Affiliated Hospital of Jinan University — Jinan
- Xi'An International Medical Center Hospital — Xi’an
- No.1 Affiliated Hospital of Xian Jiaotong University — Xi’an
- Beijing Tsinghua Changgung Hospital — Beijing
- The Third Affiliated Hospital of Naval Medical University — Shanghai
Identifiers
NCT: NCT06712017 · ST-GPN00561-CP001