Liver Cancer (Primary and Metastatic)SEGWAYNCT06229080
Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
A study testing NexGel in people with Liver Cancer (Primary and Metastatic), run by Next Biomedical Co., Ltd. at 1 site in South Korea.
Trial summary
The SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90 radioembolization of liver cancer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Liver Cancer (Primary and Metastatic)
- What is being tested?
- NexGel
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Mar 2023to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 19 years or older
- Patients diagnosed with primary or metastatic liver cancer based on histological and/or radiological findings
- Patients determined, following medical, surgical, or multidisciplinary evaluation, to be best treated by radioembolization
- Patients with no history of local treatments (e.g., ablation, chemoembolization) to the same hepatic lobe within the past year
- Child-Pugh class A
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- Patients whose treatment area, as determined by planning angiography, includes at least two liver segments
- Patients for whom normal liver tissue constitutes 50% or more of the treatment volume
Who cannot join
- Liver cancer with vascular invasion
- For primary liver cancer, patients who have been diagnosed with a malignancy other than the primary liver cancer within 2 years prior to study enrollment
- Patients who have undergone biliary-enteric anastomosis
- Patients with an estimated lung dose of 30 Gy or higher on pre-procedure 99mTc-MAA imaging
- Patients with a known contraindication to gelatin use
Trial locations and contacts
1 site in 1 country.
About this study
The SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90 radioembolization of liver cancer.
Read the detailed description
Short-acting gelatin sponge particles will be used during radioembolization to protect normal liver tissue in patients with liver cancer whose treatment field encompasses a substantial portion of non-tumorous liver tissue. Recanalization of the embolized hepatic artery will be assessed by angiography within 30 minutes following the procedure. Suppression of Y90 microsphere delivery to the protected, non-tumorous liver tissue will be evaluated using Y90 PET-CT imaging, by comparing the protected regions to non-protected, non-tumorous regions within the perfused area. Enhanced tumor uptake of Y90 microspheres will be quantified using the tumor-to-normal liver ratio (TNR), calculated by comparing pre-procedure SPECT-CT with post-procedure PET-CT data. Finally, preservation of liver function in protected tissue relative to unprotected tissue will be assessed six months post-procedure using signal intensity ratios on hepatobiliary phase images obtained from gadoxetic acid-enhanced MRI.
- Conditions
- Liver Cancer (Primary and Metastatic)
- Being tested
- NexGel
- Medical subject headings
- Liver Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NexGelDevice
When a planned perfused area includes two or more Couinaud segments and more than 50% of the target area is non-tumorous liver, short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver. The embolization particles will be prepared by mixing one vial of the particles with 5 mL of iodinated contrast agents and intra-arterially delivered with a microcatheter 2.0-Fr or larger. After confirming the disappearance or substantial reduction of liver parenchymal staining of the embolized area on angiography, radioembolization using Y90 glass or resin microspheres will be conducted. Digital subtraction angiography will be performed 30 minutes after the transient embolization to identify recanalization of the transiently embolized hepatic arteries.
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver. Receives: Device: NexGel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
Measured: Day 1, The day after radioembolization
Secondary outcomes (6)
Angiographic recanalization of the transiently embolized hepatic arteries
Angiographic recanalization of the transiently embolized hepatic arteries (grade 0, completely occluded; grade 1, antegrade flow visible only near the RGM injection point; grade 2, sluggish antegrade flow visible to the periphery; and grade 3, completely patent)
Measured: After Y-90 microsphere infusion, 30 minutes after embolization
Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)
Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)
Measured: Day 1, The day after radioembolization
Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver
Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver
Measured: 6 months after radioembolization
Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI
Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI
Measured: 6 months after radioembolization
Response to the treatment, as assessed by mRECIST
Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis
Measured: 6 months after radioembolization
Serious adverse event
Serious adverse event
Measured: For 6 months from radioembolization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start15 Mar 2023
- Primary completion20 Jan 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Cancer (Primary and Metastatic)Studies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Biomedical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin Woo Choi, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229080
- Sponsor's protocol ID
- GuardGel NXG001
- Acronym
- SEGWAY
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Embolization Using Gelatin Particles for FloW ModulAtion During Y90 Radioembolization
- ClinicalTrials.gov ID
- NCT06229080
- Acronym / sponsor ID
- SEGWAY / GuardGel NXG001
- Conditions
- Liver Cancer (Primary and Metastatic)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Next Biomedical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 20 Jan 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Jan 2024 (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 SEGWAY trial is a prospective, single-arm clinical study to evaluate the efficacy and safety of flow diversion to protect non-tumorous liver function using short-acting gelatin sponge particles during Yttrium-90 radioembolization of liver cancer.
Detailed description
Short-acting gelatin sponge particles will be used during radioembolization to protect normal liver tissue in patients with liver cancer whose treatment field encompasses a substantial portion of non-tumorous liver tissue. Recanalization of the embolized hepatic artery will be assessed by angiography within 30 minutes following the procedure. Suppression of Y90 microsphere delivery to the protected, non-tumorous liver tissue will be evaluated using Y90 PET-CT imaging, by comparing the protected regions to non-protected, non-tumorous regions within the perfused area. Enhanced tumor uptake of Y90 microspheres will be quantified using the tumor-to-normal liver ratio (TNR), calculated by comparing pre-procedure SPECT-CT with post-procedure PET-CT data. Finally, preservation of liver function in protected tissue relative to unprotected tissue will be assessed six months post-procedure using signal intensity ratios on hepatobiliary phase images obtained from gadoxetic acid-enhanced MRI.
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: NexGelshort-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 19 years or older
- Patients diagnosed with primary or metastatic liver cancer based on histological and/or radiological findings
- Patients determined, following medical, surgical, or multidisciplinary evaluation, to be best treated by radioembolization
- Patients with no history of local treatments (e.g., ablation, chemoembolization) to the same hepatic lobe within the past year
- Child-Pugh class A
Key exclusion criteria (5 listed)
- Liver cancer with vascular invasion
- For primary liver cancer, patients who have been diagnosed with a malignancy other than the primary liver cancer within 2 years prior to study enrollment
- Patients who have undergone biliary-enteric anastomosis
- Patients with an estimated lung dose of 30 Gy or higher on pre-procedure 99mTc-MAA imaging
- Patients with a known contraindication to gelatin use
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 |
|---|---|---|
| NexGelWhen a planned perfused area includes two or more Couinaud segments and more than 50% of the target area is non-tumorous liver, short-acting gelatin sponge particles (NexGel) will be administered to the hepatic arteries toward the non-tumorous liver. The embolization particles will be prepared by mixing one vial of the particles with 5 mL of iodinated contrast agents and intra-arterially delivered with a microcatheter 2.0-Fr or larger. After confirming the disappearance or substantial reduction of liver parenchymal staining of the embolized area on angiography, radioembolization using Y90 glass or resin microspheres will be conducted. Digital subtraction angiography will be performed 30 minutes after the transient embolization to identify recanalization of the transiently embolized hepatic arteries. | Device | Test group |
Primary outcome
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
Time frame: Day 1, The day after radioembolization
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver
6 secondary outcomes
Angiographic recanalization of the transiently embolized hepatic arteries
Time frame: After Y-90 microsphere infusion, 30 minutes after embolization
Tumor-to-normal liver ratio change between the pre-treatment SPECT-CT (99mTc-MAA injection without transient embolization) and post-treatment PET-CT (Y90 injection with transient embolization)
Time frame: Day 1, The day after radioembolization
Ratio of the Relative volumetric changes between the protected perfused liver and unprotected perfused liver
Time frame: 6 months after radioembolization
Relative signal intensity ratio between the protected perfused liver and unprotected perfused liver on a 20-minute delayed scan of gadoxetic acid-enhanced MRI
Time frame: 6 months after radioembolization
Response to the treatment, as assessed by mRECIST
Time frame: 6 months after radioembolization
Serious adverse event
Time frame: For 6 months from radioembolization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
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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. This study is not recruiting at the moment.
Jin Woo Choi principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NexGel in people with Liver Cancer (Primary and Metastatic), 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 12 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean absorbed dose ratio between the protected perfused liver and unprotected perfused liver (time frame: Day 1, The day after radioembolization). 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 12 Feb 2026.