CarcinomaNCT07252323
A Single-arm Phase II Clinical Study Investigating the Safety and Efficacy of Carbon Ion Radiotherapy in Patients With Hepatocellular Carcinoma Previously Treated With Transarterial Radioembolization (TARE)
A study testing Carbon Ion Radiotherapy in people with Carcinoma and Hepatocellular Carcinoma, run by Yonsei University at 1 site in South Korea.
Trial summary
This is a prospective, single-arm Phase II study designed to evaluate the safety and efficacy of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who demonstrate residual or recurrent disease after prior transarterial radioembolization (TARE). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular Carcinoma
- What is being tested?
- Carbon Ion Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Nov 2024to Nov 2026
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients over the age of 19 Hepatocellular carcinoma patients confirmed imagingly or histologically Patients who have a residual lesion in the TARE-treated area or have a recurrence or progressive lesion in the TARE-treated area or nearby liver and are deemed to need additional treatment when evaluating the response for more than 6 months Child-Pugh Class A (Child-Pugh score 5-6), B (CP score 7) Patients who fall within the range of lesions that can afford the baryon treatment intended in this study Patients who have minimal availability of liver excluded from treatment in terms of preservation of liver function proper liver function Patients with AST/ALT less than 5 times the upper limit of normal If you don't have blood clotting disorder ECOG performance status 2 or lower Patients who are not pregnant or who are undergoing appropriate contraception for women of childbearing age No other underlying conditions that seriously affect survival Patients who have listened to and agreed to a documented explanation and a statement of consent
Who cannot join
- If you've had external radiotherapy in your liver Patients with unresolved infections at that point Patients who have a current or other history of advanced carcinoma within 5 years a patient who underwent a liver transplant If baryon treatment is inappropriate or dangerous under the judgment of a radiologic oncologist
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
Yonsei University Health System, Severance Hospital
Seoul
Ik Jae Lee, +82-2-2228-8117, IKJAE412@YUHS.AC
About this study
This is a prospective, single-arm Phase II study designed to evaluate the safety and efficacy of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who demonstrate residual or recurrent disease after prior transarterial radioembolization (TARE). Carbon ion radiotherapy delivers highly conformal, high-linear energy transfer radiation, enabling dose escalation to hepatic tumors while minimizing exposure to surrounding normal tissues.
Eligible patients will receive carbon ion radiotherapy to target lesions, and clinical outcomes including objective response rate, progression-free survival, overall survival, and treatment-related toxicity will be systematically assessed. The study aims to determine whether carbon ion radiotherapy can provide effective local tumor control and acceptable safety in this population, thereby establishing evidence to guide its therapeutic role following TARE.
Read the detailed description
This prospective, single-arm Phase II study evaluates the safety and efficacy of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who have residual or recurrent disease after prior transarterial radioembolization (TARE). Although TARE is an important locoregional treatment, some patients exhibit incomplete response or local progression and have limited subsequent therapeutic options.
Carbon ion radiotherapy provides highly conformal dose distribution and increased biological effectiveness, enabling escalation of tumoricidal doses while sparing surrounding liver tissue and adjacent gastrointestinal organs. Eligible patients will undergo baseline assessments and multidisciplinary review to confirm suitability for treatment. Carbon ion radiotherapy will be delivered using hypofractionated regimens individualized based on tumor characteristics and organ-at-risk constraints.
Patients will be followed with scheduled imaging, laboratory tests, and toxicity assessments. Efficacy will be measured through tumor response, local control, progression-free survival, and overall survival. Safety will be evaluated according to CTCAE criteria. The study aims to determine whether carbon ion radiotherapy can serve as an effective and feasible salvage treatment for TARE-refractory or recurrent HCC.
- Conditions
- Carcinoma, Hepatocellular Carcinoma
- Being tested
- Carbon Ion Radiotherapy
- Medical subject headings
- Carcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon Ion RadiotherapyRadiation
Carbon ion radiotherapy will be delivered to residual or recurrent hepatocellular carcinoma in patients previously treated with transarterial radioembolization (TARE). Treatment will be administered using hypofractionated high-linear energy transfer radiation, with dose and fractionation individualized based on tumor size, tumor location, and organ-at-risk constraints. The aim of the intervention is to achieve enhanced local tumor control while minimizing toxicity to surrounding normal tissues
| Study group | Role | What they receive |
|---|---|---|
| Carbon Ion Radiotherapy | Experimental | Participants will receive carbon ion radiotherapy targeting residual or recurrent hepatocellular carcinoma following prior transarterial radioembolization (TARE). Treatment will be delivered using hypofractionated high-linear energy transfer radiation, with dose and fractionation individualized based on tumor size, anatomical location, and organ-at-risk constraints. The intervention aims to provide effective local tumor control while maintaining acceptable safety in patients who have limited subsequent treatment options after TARE. Receives: Radiation: Carbon Ion Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to mRECIST criteria. Tumor response will be assessed through scheduled imaging studies within 6 months after carbon ion radiotherapy.
Measured: Up to 6 months after completion of carbon ion radiotherapy
Secondary outcomes (5)
Progression-free survival (PFS)
PFS is defined as the time from the start of carbon ion radiotherapy to the first documented disease progression or death from any cause, or to the date of last follow-up.
Measured: Up to 3 years after initiation of carbon ion radiotherapy
Overall Survival (OS)
OS is defined as the time from the start of carbon ion radiotherapy to death from any cause, or to the last follow-up date for censored patients.
Measured: Up to 3 years after initiation of carbon ion radiotherapy
Time to overall tumor progression (TTP)
TTP is defined as the time from the start of carbon ion radiotherapy to progression of any target or non-target lesion, or the appearance of new intrahepatic or extrahepatic lesions.
Measured: Up to 3 years after initiation of carbon ion radiotherapy
Time to local progression
Time to local progression is defined as the interval from the start of carbon ion radiotherapy to radiologic progression within the treated liver area.
Measured: Up to 3 years after initiation of carbon ion radiotherapy
Treatment-related toxicity
Toxicity will be evaluated and graded according to CTCAE version 5.0. Toxicity follow-up continues from treatment initiation until confirmation of study completion or until the earliest start of subsequent therapy.
Measured: From treatment initiation through 30 days post-treatment, or until the next alternative therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start12 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CarcinomaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All enrolled participants will receive carbon ion radiotherapy as a single-arm interventional treatment. Outcomes will be evaluated prospectively to assess safety and efficacy in patients with hepatocellular carcinoma previously treated with TARE.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252323
- Sponsor's protocol ID
- 4-2024-1588
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase II Clinical Study Investigating the Safety and Efficacy of Carbon Ion Radiotherapy in Patients With Hepatocellular Carcinoma Previously Treated With Transarterial Radioembolization (TARE)
- ClinicalTrials.gov ID
- NCT07252323
- Acronym / sponsor ID
- 4-2024-1588
- Conditions
- Carcinoma, Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Nov 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.
This is a prospective, single-arm Phase II study designed to evaluate the safety and efficacy of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who demonstrate residual or recurrent disease after prior transarterial radioembolization (TARE). Carbon ion radiotherapy delivers highly conformal, high-linear energy transfer radiation, enabling dose escalation to hepatic tumors while minimizing exposure to surrounding normal tissues.
Eligible patients will receive carbon ion radiotherapy to target lesions, and clinical outcomes including objective response rate, progression-free survival, overall survival, and treatment-related toxicity will be systematically assessed. The study aims to determine whether carbon ion radiotherapy can provide effective local tumor control and acceptable safety in this population, thereby establishing evidence to guide its therapeutic role following TARE.
Detailed description
This prospective, single-arm Phase II study evaluates the safety and efficacy of carbon ion radiotherapy in patients with hepatocellular carcinoma (HCC) who have residual or recurrent disease after prior transarterial radioembolization (TARE). Although TARE is an important locoregional treatment, some patients exhibit incomplete response or local progression and have limited subsequent therapeutic options.
Carbon ion radiotherapy provides highly conformal dose distribution and increased biological effectiveness, enabling escalation of tumoricidal doses while sparing surrounding liver tissue and adjacent gastrointestinal organs. Eligible patients will undergo baseline assessments and multidisciplinary review to confirm suitability for treatment. Carbon ion radiotherapy will be delivered using hypofractionated regimens individualized based on tumor characteristics and organ-at-risk constraints.
Patients will be followed with scheduled imaging, laboratory tests, and toxicity assessments. Efficacy will be measured through tumor response, local control, progression-free survival, and overall survival. Safety will be evaluated according to CTCAE criteria. The study aims to determine whether carbon ion radiotherapy can serve as an effective and feasible salvage treatment for TARE-refractory or recurrent HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will receive carbon ion radiotherapy as a single-arm interventional treatment. Outcomes will be evaluated prospectively to assess safety and efficacy in patients with hepatocellular carcinoma previously treated with TARE.
| Arm | Type | Receives |
|---|---|---|
| Carbon Ion Radiotherapy | Experimental | Radiation: Carbon Ion RadiotherapyParticipants will receive carbon ion radiotherapy targeting residual or recurrent hepatocellular carcinoma following prior transarterial radioembolization (TARE). Treatment will be delivered using hypofractionated high-linear energy transfer radiation, with dose and fractionation individualized based on tumor size, anatomical location, and organ-at-risk constraints. The intervention aims to provide effective local tumor control while maintaining acceptable safety in patients who have limited subsequent treatment options after TARE. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients over the age of 19 Hepatocellular carcinoma patients confirmed imagingly or histologically Patients who have a residual lesion in the TARE-treated area or have a recurrence or progressive lesion in the TARE-treated area or nearby liver and are deemed to need additional treatment when evaluating the response for more than 6 months Child-Pugh Class A (Child-Pugh score 5-6), B (CP score 7) Patients who fall within the range of lesions that can afford the baryon treatment intended in this study Patients who have minimal availability of liver excluded from treatment in terms of preservation of liver function proper liver function Patients with AST/ALT less than 5 times the upper limit of normal If you don't have blood clotting disorder ECOG performance status 2 or lower Patients who are not pregnant or who are undergoing appropriate contraception for women of childbearing age No other underlying conditions that seriously affect survival Patients who have listened to and agreed to a documented explanation and a statement of consent
Key exclusion criteria (1 listed)
- If you've had external radiotherapy in your liver Patients with unresolved infections at that point Patients who have a current or other history of advanced carcinoma within 5 years a patient who underwent a liver transplant If baryon treatment is inappropriate or dangerous under the judgment of a radiologic oncologist
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 |
|---|---|---|
| Carbon Ion RadiotherapyCarbon ion radiotherapy will be delivered to residual or recurrent hepatocellular carcinoma in patients previously treated with transarterial radioembolization (TARE). Treatment will be administered using hypofractionated high-linear energy transfer radiation, with dose and fractionation individualized based on tumor size, tumor location, and organ-at-risk constraints. The aim of the intervention is to achieve enhanced local tumor control while minimizing toxicity to surrounding normal tissues | Radiation | Carbon Ion Radiotherapy |
Primary outcome
Objective Response Rate (ORR)
Time frame: Up to 6 months after completion of carbon ion radiotherapy
Objective response rate is defined as the proportion of patients achieving complete response (CR) or partial response (PR) according to mRECIST criteria. Tumor response will be assessed through scheduled imaging studies within 6 months after carbon ion radiotherapy.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Up to 3 years after initiation of carbon ion radiotherapy
Overall Survival (OS)
Time frame: Up to 3 years after initiation of carbon ion radiotherapy
Time to overall tumor progression (TTP)
Time frame: Up to 3 years after initiation of carbon ion radiotherapy
Time to local progression
Time frame: Up to 3 years after initiation of carbon ion radiotherapy
Treatment-related toxicity
Time frame: From treatment initiation through 30 days post-treatment, or until the next alternative therapy
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 26 Nov 2025.
- Individual participant dataSharing planned: Undecided
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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.
Yonsei University Health System, Severance Hospital
Seoul, South Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon Ion Radiotherapy in people with Carcinoma and Hepatocellular Carcinoma, run by Yonsei University 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 1 inclusion and 1 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 26 Nov 2025. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 6 months after completion of carbon ion radiotherapy). 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 26 Nov 2025.