Hepatocellular Carcinoma (HCC)Phase 2BEAT-UT7NCT06773845
Building Evidence for Ablative Internal Radiation Therapy in Localized HCC Beyond the Up-To-7 Criteria
A Phase 2 study testing TheraSphere in people with Hepatocellular Carcinoma (HCC) and Radioembolization, run by Seoul National University Hospital at 8 sites in South Korea.
Trial summary
At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Radioembolization
- What is being tested?
- TheraSphere
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 11 Mar 2025to 31 Dec 2030
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 19 and over
- HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease
- Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors > 7
- Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments
- No current or previous HCC in the untreated liver (i.e., future liver remnant [FLR])
- FLR volume > 30% of total non-tumorous liver volume
Show all 20Show fewer
- Child-Pugh class A
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- No major organ dysfunction according to blood test performed within two months of study enrollment:
- Leukocytes ≥ 2,000/µL and ≤ 15,000/µL
- Hemoglobin ≥ 8.0 g/dL (transfusion allowed to meet this criterion)
- Total bilirubin ≤ 2.0 mg/dL
- Platelet ≥ 40,000/µL
- International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants
- Aspartate transaminase (AST) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
- Alanine transaminase (ALT) ≤ 200 IU/L (i.e., ≤ 5X upper normal limit)
- Creatinine ≤ 2.5 mg/dL
- Patients with a life expectancy of more than 3 months
- For women of childbearing age, a negative serum pregnancy test
- Patients who have adequately understood the clinical trial and consented in writing
Who cannot join
- HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)
- HCC with extrahepatic spread on chest CT and abdominal CT or MRI
- Multinodular disseminated HCC: largest tumor size < 6 cm, or number of tumors > 10
- Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA):
- Cases where the estimated lung dose exceeds 30 Gy when 350 Gy of tumor absorbed dose is administered to the tumor based on the multicompartment Medical Internal Radiation Dose (MIRD) model
- Cases with severe hepatic artery-portal vein shunting that might lead to irradiation of the non-tumorous liver segments
Show all 11Show fewer
- Cases where the operator determines that there is substantial adhesion with the surrounding organs such as the bowel, making ablative radioembolization infeasible
- Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT
- Patients who have had active cancer within the last two years prior to the study enrollment
- History of severe allergy of intolerance to contrast agents
- Contraindication to angiography or selective visceral catheterization
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mina Lee contact
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, 14068
Lyo Min Kwon, +82 313803880, lyominkwon@hallym.or.kr
Lyo Min Kwon, MD
- Recruiting
Gangneung Asan Hospital
Gangneung, Gangwon-do, 25440
Young Jong Cho, MD, +82 336103114, ohggamja@gmail.com
Young Jong Cho, MD
- Recruiting
National Cancer Center
Ilsan, Gyeonggi-do, 10408
In Joon Lee, MD, PhD, +82 319200114, 2injoon@hanmail.net
In Joon Lee, MD, PhD
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Gun Young Kim, MD, +82 317871262, kky2kkw@gmail.com
Gun Young Kim, MD, PhD
- Recruiting
Seoul National University Hospital
Seoul, 03080
Hyun Hee Lee, +82 220724177, redlion55@snu.ac.kr
Jin Woo Choi, MD, PhD
- Recruiting
Severance Hospital
Seoul, 03722
Gyoung Min Kim, MD, PhD, + 82 222288352, kimgm@yonsei.ac.kr
Gyoung Min Kim, MD, PhD
- Not yet recruiting
Seoul Asan Hospital
Seoul, 05505
Sori Park, +82 230104359, 96sorisori@gmail.com
Dong Il Gwon, MD, PhD
- Recruiting
Samsung Medical Center
Seoul, 06351
Ji Hye Seong, +82 260075468, jh0331.seong@sbri.co.kr
Dongho Hyun, MD, PhD
About this study
Official title: Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria
At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.
Read the detailed description
This prospective, multi-center, open-label, single-arm, phase II clinical trial aims to evaluate the efficacy and safety of ablative radioembolization in patients with hepatocellular carcinoma (HCC) that exceeds the up-to-seven (UT7) criteria but is confined to up to five geographically adjacent Couinaud segments. The primary endpoint is the objective response rate, assessed according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
All patients will receive ablative radioembolization using Yttrium-90 glass microspheres with a personalized dosimetry approach targeting a tumor dose of 700 Gy (±50%). In cases of high tumor burden, a second radioembolization within 180 days of the initial procedure will be permitted at the operators' discretion, provided the cumulative lung dose remains below 50 Gy. Follow-up evaluations, including laboratory tests and dynamic imaging, will be performed at 4 weeks post-treatment and every 3 months thereafter for a total of 2 years. Efficacy data-including tumor response and survival-will be collected, with tumor responses evaluated by both site investigators and a blinded independent central review. Adverse events will be documented and graded according to the Common Terminology Criteria for Adverse Events v5.0. In addition, the incidence of radioembolization-induced liver disease and radiation pneumonitis will be monitored for 6 months following the procedure.
- Conditions
- Hepatocellular Carcinoma (HCC), Radioembolization
- Being tested
- TheraSphere
- Keywords
- Hepatocellular carcinoma, Radioembolization, SIRT
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSphereDevice
Also called Y90 glass microsphere
The multicompartment MIRD model (a.k.a. partition model) based on diagnostic CT/MRI and 99mTc-MAA SPECT-CT will be used to plan a targeted dose of 700 Gy (± 50%) to the tumor. Given the high tumor burden, a scheduled second radioembolization within 120 days from the initial treatment will be permitted at the discretion of the operators provided the cumulative lung dose remains below 50 Gy. A scheduled second radioembolization may be considered when the largest tumor diameter exceeds 8 cm, or the estimated lung dose reaches 30 Gy while the tumor absorbed dose remains below the target dose of 700 Gy. The radioactive microsphere delivery device used will be glass-based (TheraSphere; Boston Scientific, MA, USA), in which Y90 is an integral constituent of the biocompatible glass matrix. Dosimetry planning will be made by personalized dosimetry software (Simplicit90y; Boston Scientific).
| Study group | Role | What they receive |
|---|---|---|
| Radioembolization | Experimental | Ablative radioembolization using Yttrium-90 glass microspheres Receives: Device: TheraSphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) according to the mRECIST
The number of patients with partial or complete response accroding to the mRECIST as the best response, divided by the total number of participants (%)
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Secondary outcomes (15)
ORR according to the RECIST 1.1
The number of patients with partial or complete response according to the RECIST 1.1 as the best response, divided by the total number of participants (%)
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
ORR according to localized mRECIST and RECIST 1.1
The number of patients with partial or complete response as the best response, divided by the total number of participants (%). In the localized mRECIST and RECIST 1.1, the tumor response is assessed only within radioembolization-treated area.
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Duration of response according to mRECIST, localized mRECIST, and RECIST 1.1
The time from the first documentation of partial or complete response to the first occurrence of progressive disease, death from any cause, or receipt of subsequent anticancer treatment, whichever comes first.
Measured: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Overall survival rate
Measured: Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Progression-free survival rates according to mRECIST, localized mRECIST, and RECIST 1.1
Measured: Time of treatment up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Time-to-progression according to mRECIST, localized mRECIST, and RECIST 1.1
Measured: Time of treatment up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled).
Major pathologic response rate (%) after surgical resection or liver transplantation
The number of patients with major pathologic response of the largest tumor after surgical resection or liver transplantation, divided by the total number of participants who received surgical resection or liver transplanation (%). Major pathologic response refers to ≥ 90% of pathologic necrosis of the largest resected tumor
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Curative conversion rate
Curative conversion: resection, liver transplantation, or percutaneous ablation
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Sustainable complete response rate according to mRECIST more than 1 year
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Locoregional treatment unsuitability rate
LRT unsuitability will be determined if any of the following criteria are met.
- Lack of objective response after two sessions of intra-arterial treatments
- Development of new HCC within the treatment zone
- Development of vascular invasion within the treatment zone
- Development of extrahepatic spread
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Time to and reason for subsequent HCC treatment
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Threshold tumor absorbed dose (Gy) to predict radiologic complete response and objective response as the best response by localized mRECIST
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Adverse event and serious adverse event according to CTCAE v5.0
Measured: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
The presence or absence of radiation pneumonitis diagnosed by chest simple X-ray or CT
Measured: Time of treatment up to 180 days after the initial treatment or subsequent anticancer treatment, whichever comes first
The presence or absence of radioembolization-induced liver disease
Measured: Time of treatment up to 180 days after the initial treatment or subsequent anticancer treatment, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start11 Mar 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Jin Woo Choi, Seoul National University Hospital
- Investigators
- Jin Woo Choi, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773845
- Sponsor's protocol ID
- 2412-135-1601
- Acronym
- BEAT-UT7
- Status last verified
- Aug 2026
- First submitted
- 7 Jan 2025
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Evidence for Ablative Internal Radiation Therapy Using Yttrium-90 Glass Microspheres in Localized Hepatocellular Carcinoma Beyond the Up-To-7 Criteria
- ClinicalTrials.gov ID
- NCT06773845
- Acronym / sponsor ID
- BEAT-UT7 / 2412-135-1601
- Conditions
- Hepatocellular Carcinoma (HCC), Radioembolization
- Keywords
- Hepatocellular carcinoma, Radioembolization, SIRT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 11 Mar 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 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.
At four major centers in Korea, patients with hepatocellular carcinoma (HCC) that exceed the up-to-7 criteria yet remain locally confined will undergo ablative radioembolization using Yttrium-90 glass microspheres, guided by a standardized dosimetry method. Their treatment response, survival outcomes, and adverse events will be monitored for two years following the procedure.
Detailed description
This prospective, multi-center, open-label, single-arm, phase II clinical trial aims to evaluate the efficacy and safety of ablative radioembolization in patients with hepatocellular carcinoma (HCC) that exceeds the up-to-seven (UT7) criteria but is confined to up to five geographically adjacent Couinaud segments. The primary endpoint is the objective response rate, assessed according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST).
All patients will receive ablative radioembolization using Yttrium-90 glass microspheres with a personalized dosimetry approach targeting a tumor dose of 700 Gy (±50%). In cases of high tumor burden, a second radioembolization within 180 days of the initial procedure will be permitted at the operators' discretion, provided the cumulative lung dose remains below 50 Gy. Follow-up evaluations, including laboratory tests and dynamic imaging, will be performed at 4 weeks post-treatment and every 3 months thereafter for a total of 2 years. Efficacy data-including tumor response and survival-will be collected, with tumor responses evaluated by both site investigators and a blinded independent central review. Adverse events will be documented and graded according to the Common Terminology Criteria for Adverse Events v5.0. In addition, the incidence of radioembolization-induced liver disease and radiation pneumonitis will be monitored for 6 months following the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radioembolization | Experimental | Device: TheraSphereAblative radioembolization using Yttrium-90 glass microspheres |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Adult aged 19 and over
- HCC diagnosed by histology or non-invasive criteria of the American Association for the Study of Liver Disease
- Unresectable HCC beyond the UT7 criteria: the sum of the diameter of the largest tumor (cm) and the number of tumors > 7
- Localized HCC: all tumors are in the one to five geographically adjacent Couinaud segments
- No current or previous HCC in the untreated liver (i.e., future liver remnant [FLR])
Key exclusion criteria (11 listed)
- HCC with vascular invasion and/or bile duct invasion on dynamic computed tomography (CT) or magnetic resonance imaging (MRI)
- HCC with extrahepatic spread on chest CT and abdominal CT or MRI
- Multinodular disseminated HCC: largest tumor size < 6 cm, or number of tumors > 10
- Patients who are not suitable for ablative radioembolization as indicated by pre-treatment mapping with 99mTc-macroaggregated albumin (MAA):
- Cases where the operator judges that the occurrence of even mild radiation pneumonitis could be fatal, based on marked emphysema or interstitial lung disease findings on chest CT
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 |
|---|---|---|
| TheraSphereAlso: Y90 glass microsphereThe multicompartment MIRD model (a.k.a. partition model) based on diagnostic CT/MRI and 99mTc-MAA SPECT-CT will be used to plan a targeted dose of 700 Gy (± 50%) to the tumor. Given the high tumor burden, a scheduled second radioembolization within 120 days from the initial treatment will be permitted at the discretion of the operators provided the cumulative lung dose remains below 50 Gy. A scheduled second radioembolization may be considered when the largest tumor diameter exceeds 8 cm, or the estimated lung dose reaches 30 Gy while the tumor absorbed dose remains below the target dose of 700 Gy. The radioactive microsphere delivery device used will be glass-based (TheraSphere; Boston Scientific, MA, USA), in which Y90 is an integral constituent of the biocompatible glass matrix. Dosimetry planning will be made by personalized dosimetry software (Simplicit90y; Boston Scientific). | Device | Radioembolization |
Primary outcome
Objective response rate (ORR) according to the mRECIST
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
The number of patients with partial or complete response accroding to the mRECIST as the best response, divided by the total number of participants (%)
15 secondary outcomes
ORR according to the RECIST 1.1
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
ORR according to localized mRECIST and RECIST 1.1
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Duration of response according to mRECIST, localized mRECIST, and RECIST 1.1
Time frame: Time of response up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Overall survival rate
Time frame: Time of treatment up to participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Progression-free survival rates according to mRECIST, localized mRECIST, and RECIST 1.1
Time frame: Time of treatment up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Time-to-progression according to mRECIST, localized mRECIST, and RECIST 1.1
Time frame: Time of treatment up to progression, subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled).
Major pathologic response rate (%) after surgical resection or liver transplantation
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Curative conversion rate
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Sustainable complete response rate according to mRECIST more than 1 year
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Locoregional treatment unsuitability rate
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Time to and reason for subsequent HCC treatment
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Threshold tumor absorbed dose (Gy) to predict radiologic complete response and objective response as the best response by localized mRECIST
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
Adverse event and serious adverse event according to CTCAE v5.0
Time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)
The presence or absence of radiation pneumonitis diagnosed by chest simple X-ray or CT
Time frame: Time of treatment up to 180 days after the initial treatment or subsequent anticancer treatment, whichever comes first
The presence or absence of radioembolization-induced liver disease
Time frame: Time of treatment up to 180 days after the initial treatment or subsequent anticancer treatment, whichever comes first
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 20 Aug 2026.
- 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.
Mina Lee contact
Jin Woo Choi, MD, PhD study chair
Seoul National University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TheraSphere in people with Hepatocellular Carcinoma (HCC) and Radioembolization, run by Seoul National University Hospital at 8 sites 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 20 inclusion and 11 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 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Hyun Hee Lee (+82 220724177, redlion55@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) according to the mRECIST (time frame: Time of treatment up to subsequent anti-cancer therapy, participant's death, opposition to data collection, lost to follow-up, or study termination (24 months after the last patient is enrolled)). 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 20 Aug 2026.