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A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
Sponsor: InnoBM Pharmaceuticals Co., Ltd.
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
Conditions
Interventions
Magnesium Microspheres
Biodegradable Magnesium Embolic Microspheres
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