Observational Study for SIR-Spheres Therapy for the Treatment of HCC Patients in China

Grand Pharmaceutical Group

Status: Invitation-only

Conditions: Hepatocellular Carcinoma Non-Resectable; Hepatocellular Carcinoma (HCC)

Treatments: Device: Yttrium-90 (Y-90) resin microspheres

Study type: Observational

Funder types: Industry

Identifiers

NCT06712017

ST-GPN00561-CP001

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

adult HCC patients treated with yttrium90

Treatment:

Device: Yttrium-90 (Y-90) resin microspheres