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Enrolling by Invitation

NCT Number: NCT06712017

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

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.

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Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Non-resectable Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Yttrium-90 (Y-90) resin microspheres

Device

selective internal radiation therapy

Primary outcomes

  1. best hepatic ORR measured by mRECIST criteria

    Time frame: 6 months following y90 therapy

Secondary outcomes

  1. ORR measured by mRECIST criteria

    Time frame: 6 months following y90 therapy

  2. OS

    Time frame: From date of first Y90 therapy until the date of death from any cause, assessed up to 24 months

  3. TTP

    Time frame: From date of first Y90 therapy until the date of first documented progression, assessed up to 24 months

    time to progression

  4. 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

  5. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Time frame: 6 months following y90 therapy

Sponsors and collaborators

Lead sponsor

GrandPharma (China) Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 2, 2024
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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