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

NCT06712017 | Enrolling By Invitation

• 1 other identifier: ST-GPN00561-CP001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC); Hepatocellular Carcinoma Non-Resectable

Keywords

yttrium 90; y-90; HCC; SIRT

Outcome Measures

Primary Outcomes (1)

• best hepatic ORR measured by mRECIST criteria

  6 months following y90 therapy

Secondary Outcomes (5)

• ORR measured by mRECIST criteria

  6 months following y90 therapy

• OS

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

• TTP

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

• PFS

  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

  6 months following y90 therapy

Study Arms (1)

adult HCC patients treated with yttrium90

Device: Yttrium-90 (Y-90) resin microspheres

Interventions

Yttrium-90 (Y-90) resin microspheres DEVICE

selective internal radiation therapy

adult HCC patients treated with yttrium90

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• GrandPharma (China) Co., Ltd.: lead

Study Sites (6)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Jinan University

Jinan, Guangdong, China

Location

Xi'An International Medical Center Hospital

Xi’an, Guangxi, China

Location

No.1 Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

The Third Affiliated Hospital of Naval Medical University

Shanghai, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xiaobin Feng, MD

  Beijing Tsinghua Changgeng Hospital

  PRINCIPAL INVESTIGATOR

• Kangshun Zhu, MD

  Second Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

• Yefa Yang, MD

  Eastern Hepatobiliary Surgery Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: December 2, 2024
• Study Start: August 22, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

CN (6)