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NOT YET RECRUITING
NCT06779461
PHASE3

A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma

Sponsor: InnoBM Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to determine if the addition of biodegradable magnesium metal microspheres to traditional TACE (Transarterial Chemoembolization) is effective in treating hepatocellular carcinoma, and to assess the safety of these microspheres. The main questions it aims to answer are: * Is the treatment more effective than traditional TACE alone? * What additional medical issues arise when using the microspheres? Researchers will compare TACE with magnesium microspheres to traditional TACE without microspheres to see if the addition of the microspheres improves treatment outcomes. Participants will: * Receive up to 3 treatments of TACE with or without microspheres * Undergo checkups and tests every 30 days * Keep records of tumor size and other safety issues

Official title: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2025-01

Completion Date

2027-12

Last Updated

2025-01-16

Healthy Volunteers

No

Interventions

DEVICE

Magnesium Microspheres

Biodegradable Magnesium Embolic Microspheres

PROCEDURE

cTACE

cTACE

Locations (10)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Anyang Tumor Hospital

Anyang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

Lishui Central Hospital

Lishui, Zhejiang, China

The Third Affiliated Hospital,Sun Yat-Sen University

Guangzhou, China

The First Hospital of Lanzhou University

Lanzhou, China

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China