Hepatocellular Carcinoma Non-ResectablePhase 3NCT06779461
A Clinical Trial Assessing the Safety and Efficacy of Biodegradable Magnesium Embolic Microspheres for Primary Hepatocellular Carcinoma
A Phase 3 study testing Magnesium Microspheres and cTACE in people with Hepatocellular Carcinoma Non-Resectable, run by InnoBM Pharmaceuticals Co., Ltd. at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-Resectable
- What is being tested?
- Magnesium Microspheres and cTACE
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 10 sitesChina
- Study dates
- Jan 2025to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Anyang Tumor Hospital
Anyang, Henan
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui
The Third Affiliated Hospital,Sun Yat-Sen University
Guangzhou
The First Hospital of Lanzhou University
Lanzhou
Lishui Central Hospital
Lishui, Zhejiang
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Fudan University Shanghai Cancer Center
Shanghai
Tianjin Medical University Cancer Institute & Hospital
Tianjin
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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
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:
Read more
- 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
- Being tested
- Magnesium Microspheres, cTACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium MicrospheresDevice
Biodegradable Magnesium Embolic Microspheres
cTACEProcedure or surgery
cTACE
| Study group | Role | What they receive |
|---|---|---|
| cTACE | Placebo comparator | Not described Receives: Procedure: cTACE |
| cTACE with magnesium microspheres | Experimental | Not described Receives: Device: Magnesium Microspheres; Procedure: cTACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The objective response rate of the target lesion
Measured: 30 days after the last TACE treatment.
Secondary outcomes (4)
Success rate of embolization technique for the target lesion
Success rate of embolization technique for the target lesion
Measured: on the day of the surgery
DCR
Disease control rate of the target lesion
Measured: 30 days after the first TACE treatment
CR
Complete Response of the target lesion
Measured: 30 days after the first TACE treatment
ORR
Objective Response Rate of the target lesion
Measured: 90 days after the last TACE treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2025
- Study startJan 2025 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-ResectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoBM Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779461
- Sponsor's protocol ID
- BM601-Q001
- Status last verified
- Dec 2024
- First submitted
- 25 Dec 2024
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06779461
- Acronym / sponsor ID
- BM601-Q001
- Conditions
- Hepatocellular Carcinoma Non-Resectable
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- InnoBM Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- CHONGQING BAIMAITENGSHI PHARMACEUTICAL TECHNOLOGY CO., LTD
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cTACE | Placebo comparator | Procedure: cTACE |
| cTACE with magnesium microspheres | Experimental | Device: Magnesium Microspheres, Procedure: cTACE |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium MicrospheresBiodegradable Magnesium Embolic Microspheres | Device | cTACE with magnesium microspheres |
| cTACEcTACE | Procedure or surgery | cTACE, cTACE with magnesium microspheres |
Primary outcome
ORR
Time frame: 30 days after the last TACE treatment.
The objective response rate of the target lesion
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Magnesium Microspheres and cTACE in people with Hepatocellular Carcinoma Non-Resectable, run by InnoBM Pharmaceuticals Co., Ltd. at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chuntao G PM (86+0512 6938 6599, ctgong@innobm.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 30 days after the last TACE treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.