Clinical trial · Observational
Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Hepatocellular Carcinoma Non-Resectable | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium-90 (Y-90) resin microspheres | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- adult HCC patients treated with yttrium90
- interventionNames
- Device: Yttrium-90 (Y-90) resin microspheres
Primary outcomes (1)
- measure
- best hepatic ORR measured by mRECIST criteria
- timeFrame
- 6 months following y90 therapy
Secondary outcomes (5)
- measure
- ORR measured by mRECIST criteria
- timeFrame
- 6 months following y90 therapy
- measure
- OS
- timeFrame
- From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 exclusion criteria in a real-world study
References
Publications (0)
Data not yet available