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

ConditionHepatocellular Carcinoma Non-Resectable
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorInnoBM Pharmaceuticals Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnesium Microspheres

    Device

    Biodegradable Magnesium Embolic Microspheres

  • cTACE

    Procedure/Surgery

    cTACE

Treatment groups

228 Participants
are divided into 2 treatment groups
Group A: cTACEPlacebo comparator 1 intervention
Group B: cTACE with magnesium microspheresExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

ORR

The objective response rate of the target lesion

Time frame
30 days after the last TACE treatment.

Secondary outcomes

1

Success rate of embolization technique for the target lesion

Success rate of embolization technique for the target lesion

Time frame
on the day of the surgery
2

DCR

Disease control rate of the target lesion

Time frame
30 days after the first TACE treatment
3

CR

Complete Response of the target lesion

Time frame
30 days after the first TACE treatment
4

ORR

Objective Response Rate of the target lesion

Time frame
90 days after the last TACE treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

InnoBM Pharmaceuticals Co., Ltd.

Lead sponsor

CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: