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Not yet recruiting NCT06779461

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

Phase III Interventional Hepatocellular Carcinoma Non-Resectable

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnesium Microspheres, cTACE.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma Non-Resectable. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

  • Device Magnesium Microspheres
    Biodegradable Magnesium Embolic Microspheres
  • Procedure cTACE
    cTACE

Primary outcome measures

  • ORR [Time frame: 30 days after the last TACE treatment.]
Secondary outcome measures (4)
  • Success rate of embolization technique for the target lesion [Time frame: on the day of the surgery]
  • DCR [Time frame: 30 days after the first TACE treatment]
  • CR [Time frame: 30 days after the first TACE treatment]
  • ORR [Time frame: 90 days after the last TACE treatment]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • Factors affecting study results or necessitating study termination (alcoholism, drug abuse, severe diseases);
  • Severe infections unsuitable for TACE;
  • Participation in other clinical trials within 28 days before enrollment;
  • Other reasons deemed unsuitable by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 10 centers
  • The First Affiliated Hospital of Bengbu Medical University — Bengbu
  • Anyang Tumor Hospital — Anyang
  • Henan Cancer Hospital — Zhengzhou
  • Zhongda Hospital Southeast University — Nanjing
  • Lishui Central Hospital — Lishui
  • The Third Affiliated Hospital,Sun Yat-Sen University — Guangzhou
  • The First Hospital of Lanzhou University — Lanzhou
  • The First Affiliated Hospital of Henan University of Science & Technology — Luoyang
  • … and 2 more centers

Identifiers

NCT: NCT06779461 · BM601-Q001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗