Hepatocellular CarcinomaNCT05072041
Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma
A study testing Nexsphere™ in people with Hepatocellular Carcinoma, run by Next Biomedical Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Nexsphere™
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 31 Oct 2021to 31 Dec 2025
- Phase
- Interventional
- 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 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 19 to 79 years
- Patient who signed Informed Consent Form
- Patients diagnosed with hepatocellular carcinoma by American Association for the Study of Liver Diseases (AASLD) and at least one of the following methods i. Magnetic resonance imaging (MRI) with early augmentation and delayed excretion of at least one solid liver lesion greater than 1 ㎝.
- Contrast-enhanced computed tomography (CT) with early augmentation and delayed build-up of at least one solid liver lesion >1 ㎝.
- Lesions with inconclusive features require histological confirmation.
- Patients should not be eligible for treatment by amputation or percutaneous resection or liver transplantation at the time of study enrollment.
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- Patients who are not suitable for ablation due to lesion location may be enrolled.
- Patients with recurrent hepatocellular carcinoma who are not suitable for amputation or resection may be enrolled.
- Must be Child-Pugh A or B hepatocellular carcinoma, and must satisfy the following criteria.
- Tumor lesion size from 1 ㎝ to 10 ㎝ ii. Number of tumors 1-7 iii. Physical activity European Cooperative Oncology Group (ECOG) ≤ 1 without vascular involvement
- Patients who can be followed up until the end of the study and whose life expectancy is 6 months or longer
Who cannot join
- Patients under the age of 19
- Chronic kidney disease (CDK) grade 4 or 5 patients
- Current or previous treatment with chemotherapy or radiation therapy or sorafenib or drug release chemoembolization (deTACE) after diagnosis of hepatocellular carcinoma
- 5. Pregnant, lactating, pre-menopausal and women not using effective contraceptive methods 6. Performance state European Cooperative Oncology Group (ECOG) > 1 7. Child-Poo Class C 8. Advanced hepatocellular carcinoma with vascular invasion or extrahepatic metastasis 9. Active Gastrointestinal Bleeding 10. Evidence of irreversible bleeding constitution 11. Encephalopathy that is not medically adequately controlled 12. Presence of ascites that is not medically controlled 13. Contraindications to Magnetic Resonance Imaging or Computed Tomography scan (e.g. metal implants) 14. Allergy to contrast media that cannot be managed by prevention 15. Contraindications to angiography 16. Contraindications to the administration of cisplatin anticancer drugs 17. Contraindications to hepatic artery embolization
- Extensive context-to-systemic shunts
- hepatofugal portal blood flow
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- Serum bilirubin > 3.0 ㎎/dL
- Serum creatinine > 2.0 ㎎/dL
- Other symptoms that your doctor has determined to be exclusive.
- Irreversible blood clotting disorders 18. Others who are judged to be difficult for the principal investigator or principal investigator to conduct this clinical trial for other reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul, Seoul, 05505
Dong Il Gwon, MD, PhD, 82-2-30110-5001, radgwon@amc.seoul.kr
About this study
Official title: Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Prospective Comparative Study
The purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment.
Read the detailed description
This study is a prospective study, and the purpose of this study is to investigate and collect clinical information on the safety and efficacy of degradable microsphere for hepatic artery chemoembolization in hepatocellular carcinoma patients. The primary purpose of this study was to evaluate the incidence of postembolism syndrome and liver function impairment after hepatic artery chemoembolization, and the secondary purpose was to evaluate tumor treatment response and hepatic artery damage after 1 month of hepatic artery chemoembolization.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Nexsphere™
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nexsphere™Device
Nexsphere™ is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Degradable embolic microsphere (Nexsphere™) Receives: Device: Nexsphere™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postembolism syndrome
Nausea, vomiting, persistent pain, fever, and other
Measured: 8 weeks
Incidence of liver function impairment
AFP, AST, ALT, BILI, GGT, BUN, and CREAT level
Measured: 8 weeks
Secondary outcomes (2)
Tumor treatment response
Evaluation of tumor size by Magnetic Resonance Imaging or Computed Tomography scan at 4 and 8 weeks after embolization
Measured: 8 weeks
Hepatic artery damage
Vessel dissection, vessel stenosis, vessel occlusion, vessel wall irregularity, and other
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start31 Oct 2021
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Il Gwon, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072041
- Sponsor's protocol ID
- NEXTBIO-UIGB-HCC01
- Status last verified
- Nov 2024
- First submitted
- 28 Sep 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Degradable Microsphere in Transcatheter Arterial Chemoembolization for Hepatocellular Carcinoma: a Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT05072041
- Acronym / sponsor ID
- NEXTBIO-UIGB-HCC01
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2021 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 8 Oct 2021 (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 purpose of this study was to prospectively collect clinical data from patients who underwent hepatic artery chemoembolization using microspheres with different degradation times (2 hours, 1 day, 2 weeks) based on standard treatment.
Detailed description
This study is a prospective study, and the purpose of this study is to investigate and collect clinical information on the safety and efficacy of degradable microsphere for hepatic artery chemoembolization in hepatocellular carcinoma patients. The primary purpose of this study was to evaluate the incidence of postembolism syndrome and liver function impairment after hepatic artery chemoembolization, and the secondary purpose was to evaluate tumor treatment response and hepatic artery damage after 1 month of hepatic artery chemoembolization.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Device: Nexsphere™Degradable embolic microsphere (Nexsphere™) |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Adult patients aged 19 to 79 years
- Patient who signed Informed Consent Form
- Patients diagnosed with hepatocellular carcinoma by American Association for the Study of Liver Diseases (AASLD) and at least one of the following methods i. Magnetic resonance imaging (MRI) with early augmentation and delayed excretion of at least one solid liver lesion greater than 1 ㎝.
- Patients should not be eligible for treatment by amputation or percutaneous resection or liver transplantation at the time of study enrollment.
- Must be Child-Pugh A or B hepatocellular carcinoma, and must satisfy the following criteria.
Key exclusion criteria (10 listed)
- Patients under the age of 19
- Chronic kidney disease (CDK) grade 4 or 5 patients
- Current or previous treatment with chemotherapy or radiation therapy or sorafenib or drug release chemoembolization (deTACE) after diagnosis of hepatocellular carcinoma
- 5. Pregnant, lactating, pre-menopausal and women not using effective contraceptive methods 6. Performance state European Cooperative Oncology Group (ECOG) > 1 7. Child-Poo Class C 8. Advanced hepatocellular carcinoma with vascular invasion or extrahepatic metastasis 9. Active Gastrointestinal Bleeding 10. Evidence of irreversible bleeding constitution 11. Encephalopathy that is not medically adequately controlled 12. Presence of ascites that is not medically controlled 13. Contraindications to Magnetic Resonance Imaging or Computed Tomography scan (e.g. metal implants) 14. Allergy to contrast media that cannot be managed by prevention 15. Contraindications to angiography 16. Contraindications to the administration of cisplatin anticancer drugs 17. Contraindications to hepatic artery embolization
- Extensive context-to-systemic shunts
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 |
|---|---|---|
| Nexsphere™Nexsphere™ is a yellow powder, made of 100% hydrophilic gelatin. It is used to make a suspension by mixing a contrast agent and physiological saline. The indications are hepatic artery chemoembolization, uterine artery embolization, prostate artery embolization, and treatment of various hemorrhagic diseases. It physically embolizes blood vessels and is decomposed within 4-8 weeks after intravascular injection. | Device | Test group |
Primary outcome
Incidence of postembolism syndrome
Time frame: 8 weeks
Nausea, vomiting, persistent pain, fever, and other
Incidence of liver function impairment
Time frame: 8 weeks
AFP, AST, ALT, BILI, GGT, BUN, and CREAT level
2 secondary outcomes
Tumor treatment response
Time frame: 8 weeks
Hepatic artery damage
Time frame: 8 weeks
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 14 Nov 2024.
- 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.
Dong Il Gwon, MD, PhD principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nexsphere™ in people with Hepatocellular Carcinoma, run by Next Biomedical Co., Ltd. at 1 site in South Korea.
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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Jin Hee Maeng, MS (+8228800860, jhmaeng@nextbiomedical.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postembolism syndrome (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 14 Nov 2024.