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

December 4, 2024 updated by: GrandPharma (China) Co., Ltd.

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Tsinghua Changgung Hospital
      • Shanghai, China
        • The Third Affiliated Hospital of Naval Medical University
    • Guangdong
      • Guangzhou, Guangdong, China
        • The second Affiliated Hospital of Guangzhou Medical University
      • Jinan, Guangdong, China
        • The First Affiliated Hospital of Jinan University
    • Guangxi
      • Xi'An, Guangxi, China
        • Xi'an International Medical Center Hospital
    • Shanxi
      • Xi'An, Shanxi, China
        • No.1 Affiliated Hospital of Xian Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

adult HCC patients treated with yttrium-90 during 2023.1.1 - 2024.6.30 and assessed at least once for tumor response within 6 months following treatment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
adult HCC patients treated with yttrium90
Device: Yttrium-90 (Y-90) resin microspheres
selective internal radiation therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
best hepatic ORR measured by mRECIST criteria
Time Frame: 6 months following y90 therapy
6 months following y90 therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR measured by mRECIST criteria
Time Frame: 6 months following y90 therapy
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
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
time to progression
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
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
6 months following y90 therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GrandPharma (China) Co., Ltd.

Investigators

  • Principal Investigator: Kangshun Zhu, MD, Second Affiliated Hospital of Guangzhou Medical University
  • Principal Investigator: Xiaobin Feng, MD, Beijing Tsinghua Changgeng Hospital
  • Principal Investigator: Yefa Yang, MD, The Third Affiliated Hospital of Naval Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 26, 2024

First Posted (Actual)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-GPN00561-CP001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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