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

NCT06712017 · tracked via the Priya Life Science China tracker

Sponsor

GrandPharma (China) Co., Ltd.

Phase

Observational

Started

2024-08-22

Last updated

2024-12-05

Condition(s) studied

Hepatocellular Carcinoma (HCC)Hepatocellular Carcinoma Non-Resectable

Investigational drug(s) / intervention(s)

Yttrium-90 (Y-90) resin microspheres

Yttrium-90 (Y-90) resin microspheres: selective internal radiation therapy

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

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

Primary outcome measure(s)

best hepatic ORR measured by mRECIST criteria — 6 months following y90 therapy

Trial sites (6)

Facility	City	Region
The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
The First Affiliated Hospital of Jinan University	Jinan	Guangdong
Xi'An International Medical Center Hospital	Xi’an	Guangxi
No.1 Affiliated Hospital of Xian Jiaotong University	Xi’an	Shanxi
Beijing Tsinghua Changgung Hospital	Beijing	China
The Third Affiliated Hospital of Naval Medical University	Shanghai	China

More GrandPharma (China) Co., Ltd. trials in China

Observational Study for SIR-Spheres Therapy for the Treatment of Unresectable Metastatic Liver Tumors From Primary Colorectal Cancer Starting soon

A Study of Yttrium [90Y] Microsphere Injection in Combination With Targeted Immunotherapy in the Treatment of HCC Recruiting

Other trials for the same condition

68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma Starting soon

To Evaluate the Safety, Tolerability, and Preliminary Efficacy of XH001 Injection as Adjuvant Therapy in Patients With High-risk Recurrent Solid Tumors Recruiting

TACE Combined With Immune Checkpoint Inhibitors for Liver Malignant Tumors Recruiting

Sintilimab Combined With Bevacizumab Biosimilar as Adjuvant Treatment After Resection of Ruptured Hepatocellular Carcinoma (CLEAR-2) Recruiting

TACE and/or HAIC Combined With Molecular-targeted Therapy and Immunotherapy for HCC Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06712017 on ClinicalTrials.gov ↗ ← All trials in China