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

NCT06779461 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2025-01-16

No results posted yet for this study

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

Conditions

  • Hepatocellular Carcinoma Non-Resectable

Interventions

DEVICE

Magnesium Microspheres

Biodegradable Magnesium Embolic Microspheres

PROCEDURE

cTACE

cTACE

Sponsors & Collaborators

  • CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD

    collaborator UNKNOWN

  • InnoBM Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06779461 on ClinicalTrials.gov