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

NCT ID: NCT06712017

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-22

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC) Hepatocellular Carcinoma Non-Resectable

Keywords

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yttrium 90 y-90 HCC SIRT

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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adult HCC patients treated with yttrium90

Yttrium-90 (Y-90) resin microspheres

Intervention Type DEVICE

selective internal radiation therapy

Interventions

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Yttrium-90 (Y-90) resin microspheres

selective internal radiation therapy

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GrandPharma (China) Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xiaobin Feng, MD

Role: PRINCIPAL_INVESTIGATOR

Beijing Tsinghua Changgeng Hospital

Kangshun Zhu, MD

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Guangzhou Medical University

Yefa Yang, MD

Role: PRINCIPAL_INVESTIGATOR

The Third Affiliated Hospital of Naval Medical University

Locations

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The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital of Jinan University

Jinan, Guangdong, China

Site Status

Xi'An International Medical Center Hospital

Xi’an, Guangxi, China

Site Status

No.1 Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

Site Status

Beijing Tsinghua Changgung Hospital

Beijing, , China

Site Status

The Third Affiliated Hospital of Naval Medical University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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ST-GPN00561-CP001

Identifier Type: -

Identifier Source: org_study_id