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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hepatocellular Carcinoma Non-Resectable
• Intervention / Treatment: Procedure: cTACE; Device: Magnesium Microspheres

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chuntao G PM; Phone Number: 86+0512 6938 6599; Email: ctgong@innobm.cn

Study Locations

• China
  • Guangzhou, China
    • the Third Affiliated Hospital,Sun Yat-Sen University
  • Lanzhou, China
    • The First Hospital of Lanzhou University
  • Luoyang, China
    • The First Affiliated Hospital of Henan University of Science & Technology
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Tianjin, China
    • Tianjin Medical University Cancer Institute & Hospital
  • Anhui
    • Bengbu, Anhui, China
      • The First Affiliated Hospital of Bengbu Medical University
  • Henan
    • Anyang, Henan, China
      • AnYang Tumor Hospital
    • Zhengzhou, Henan, China
      • Henan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Zhongda Hospital Southeast University
  • Zhejiang
    • Lishui, Zhejiang, China
      • Lishui Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range: 18 to 80 years inclusive, regardless of gender;
2. 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;
3. ECOG score ≤ 2, and Child-Pugh classification of A or B;
4. 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);
5. Patients with hepatitis B virus (HBV) or hepatitis C virus (HCV) infection who are willing to receive antiviral treatment throughout the study period;
6. Voluntary participation in this clinical trial and signing of the informed consent form by the subject.

Exclusion Criteria:

1. Patients with prior embolization or other local treatments within 28 days before enrollment, or needing combined local treatment with TACE;
2. Received other antitumor systemic treatment within 28 days before enrollment;
3. Unsuitable for TACE due to lesion characteristics or vascular issues;
4. Vp3/Vp4 portal vein tumor thrombus;
5. Tumor occupying ≥70% of liver volume;
6. Decompensated cirrhosis or recent ascites drainage/TIPS;
7. Severe allergies to contrast agents or embolization materials;
8. Received blood products or certain corrective treatments within 7 days before enrollment;
9. Abnormal blood counts (WBC, platelets, neutrophils, hemoglobin);
10. Abnormal liver function tests (bilirubin, enzymes, albumin);
11. Renal impairment (creatinine, creatinine clearance);
12. Prolonged PT;
13. Unsuitable feeding artery for TACE or embolization risks;
14. Expected survival <6 months;
15. Pregnant, lactating, or planning pregnancy;
16. Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases);
17. Severe infections unsuitable for TACE;
18. Participation in other clinical trials within 28 days before enrollment;
19. Other reasons deemed unsuitable by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: cTACE	Procedure: cTACE; cTACE
Experimental: cTACE with magnesium microspheres	Procedure: cTACE; cTACE; Device: Magnesium Microspheres; Biodegradable Magnesium Embolic Microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	The objective response rate of the target lesion	30 days after the last TACE treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of embolization technique for the target lesion	Success rate of embolization technique for the target lesion	on the day of the surgery
DCR	Disease control rate of the target lesion	30 days after the first TACE treatment
CR	Complete Response of the target lesion	30 days after the first TACE treatment
ORR	Objective Response Rate of the target lesion	90 days after the last TACE treatment

Collaborators and Investigators

• Sponsor: InnoBM Pharmaceuticals Co., Ltd.
• Collaborators: CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 25, 2024
• First Submitted That Met QC Criteria: January 10, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 10, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: BM601-Q001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No