A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
1 other identifier
interventional
228
1 country
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2025
Typical duration for phase_3
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2024
CompletedStudy Start
First participant enrolled
January 1, 2025
CompletedFirst Posted
Study publicly available on registry
January 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 16, 2025
December 1, 2024
2.4 years
December 25, 2024
January 10, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
ORR
The objective response rate of the target lesion
30 days after the last TACE treatment.
Secondary Outcomes (4)
Success rate of embolization technique for the target lesion
on the day of the surgery
DCR
30 days after the first TACE treatment
CR
30 days after the first TACE treatment
ORR
90 days after the last TACE treatment
Study Arms (2)
cTACE
PLACEBO COMPARATORcTACE with magnesium microspheres
EXPERIMENTALInterventions
Biodegradable Magnesium Embolic Microspheres
Eligibility Criteria
You may qualify if:
- Age range: 18 to 80 years inclusive, regardless of gender;
- Patients with primary hepatocellular carcinoma (HCC) at CNLC stage Ib to IIIa who require transarterial chemoembolization (TACE) treatment and are unsuitable for or refuse surgical resection, liver transplantation, and ablation therapy;
- ECOG score ≤ 2, and Child-Pugh classification of A or B;
- Presence of at least one untreated, measurable tumor lesion with a diameter ≥ 3.0 cm according to mRECIST criteria (the maximum diameter of the target lesion ≤ 10.0 cm);
- Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period;
- Voluntary participation in this clinical trial and signing of the informed consent form by the subject.
You may not qualify if:
- Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;
- Received other antitumor systemic treatment within 28 days before enrollment;
- Unsuitable for TACE due to lesion characteristics or vascular issues;
- Vp3/Vp4 portal vein tumor thrombus;
- Tumor occupying ≥70% of liver volume;
- Decompensated cirrhosis or recent ascites drainage/TIPS;
- Severe allergies to contrast agents or embolization materials;
- Received blood products or certain corrective treatments within 7 days before enrollment;
- Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin);
- Abnormal liver function tests (bilirubin, enzymes, albumin);
- Renal impairment (creatinine, creatinine clearance);
- Prolonged PT;
- Unsuitable feeding artery for TACE or embolization risks;
- Expected survival \<6 months;
- Pregnant, lactating, or planning pregnancy;
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2024
First Posted
January 16, 2025
Study Start
January 1, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 16, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share