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

G

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

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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