CancerPhase 2I-APTNCT07381231
Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
A Phase 2 study testing Pulse radiation therapy in people with Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to find out whether Adaptive Pulse Radiotherapy (Pulse RT) combined with immune checkpoint inhibitors (ICIs) helps treat advanced solid tumors. It will also check how safe this combined treatment is and how it affects the immune system and quality of life. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Pulse radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Sep 2025to 30 Sep 2031
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histologically confirmed solid tumor (radiologic diagnosis allowed for hepatocellular carcinoma)
- Currently receiving or planned to receive immune checkpoint inhibitor (ICI) therapy
- Presence of at least one lesion suitable for radiotherapy and measurable disease per RECIST version 1.1
- Ability and willingness to provide written informed consent
Who cannot join
- Pregnant or breastfeeding women
- Presence of brain metastasis or leptomeningeal metastasis
- Prior radiotherapy to the intended treatment site
- Significant comorbid conditions that may interfere with study participation or treatment (e.g., uncontrolled infection, heart failure, arrhythmia, psychiatric disorder)
- Inability or unwillingness to comply with study procedures
- Considered inappropriate for study participation by the principal investigator or treating physician
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
Samsung medical center
Seoul, 06351
Nalee Kim, MD, PhD, 82-2-3410-2612, nalee.kim@samsung.com
About this study
Official title: A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
The goal of this clinical trial is to find out whether Adaptive Pulse Radiotherapy (Pulse RT) combined with immune checkpoint inhibitors (ICIs) helps treat advanced solid tumors.
It will also check how safe this combined treatment is and how it affects the immune system and quality of life.
Read more
The main questions the study will try to answer are:
Does adding Pulse RT to ICIs improve tumor response and survival? What side effects occur when participants receive Pulse RT with ICIs? How does the treatment change immune-related blood and tissue markers? Does the treatment affect participants' quality of life?
Researchers will compare this new approach to usual ICI treatment to see whether Pulse RT makes a difference.
Participants will:
Continue to receive their standard ICI treatment. Receive 2-3 sessions of high-dose Pulse RT (8-10 Gy each) given about every 3 weeks.
Have the treatment volume adjusted based on how their tumors respond. Visit the clinic regularly for check-ups, imaging, blood tests, and quality-of-life questionnaires.
- Conditions
- Cancer
- Being tested
- Pulse radiation therapy
- Keywords
- Immunotherapy, Radiation therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse radiation therapyRadiation
Adaptive Pulse Radiotherapy (Pulse RT) is a personalized radiotherapy strategy designed to enhance anti-tumor immunity when combined with immune checkpoint inhibitors (ICIs). Patients receive 2-3 fractions of 8-10 Gy at 3-4-week intervals, with adaptive modification of target volumes according to tumor response. This approach aims to induce repeated immunogenic cell death and expand tumor-specific T-cell repertoires, thereby amplifying the efficacy of concurrent immunotherapy while maintaining safety within standard dose constraints. Both photon and proton modalities may be used, depending on lesion location and clinical judgment.
| Study group | Role | What they receive |
|---|---|---|
| Pulse RT | Experimental | Not described Receives: Radiation: Pulse radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival at 6 Months
Progression-free survival (PFS) is defined as the time from the start of Adaptive Pulse Radiotherapy (first radiation treatment) to the date of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
Measured: 6 months after first radiation therapy
Secondary outcomes (6)
Progression-Free Survival (PFS)
Progression-free survival (PFS) will be assessed using Kaplan-Meier analysis.
Measured: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Local Recurrence-Free Survival (LRFS)
Local recurrence-free survival (LRFS) is defined as the time from initiation of Adaptive Pulse Radiotherapy to local tumor recurrence within the irradiated field or death from any cause, whichever occurs first.
Measured: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Overall Survival (OS)
Overall survival (OS) is defined as the time from initiation of Adaptive Pulse Radiotherapy to death from any cause.
Measured: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of participants achieving complete or partial response according to RECIST version 1.1 criteria.
Measured: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Immune Response Profiling and Biomarker Analysis
Changes in circulating immune biomarkers, including cytokine levels (e.g., IL-6, IL-8, IL-10, TNF-β, IFN-γ) and immune cell subsets (e.g., CD3, CD4, CD8, NK cells, regulatory T cells), will be assessed in peripheral blood samples collected at specified time points.
Measured: Baseline, during treatment, 1 month after last radiation therapy
Change in Patient-Reported Quality of Life
Patient-reported outcomes will be evaluated using the PRO-CTCAE core set at baseline and during follow-up. Changes over time will be analyzed using linear mixed models to assess treatment-related symptom burden and overall quality of life trends.
Measured: Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start26 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381231
- Sponsor's protocol ID
- SMC 2025-08-014
- Other IDs
- 2025-08-014
- Acronym
- I-APT
- Status last verified
- Oct 2026
- First submitted
- 1 Dec 2025
- Last updated
- 14 Oct 2026
- 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 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
- ClinicalTrials.gov ID
- NCT07381231
- Acronym / sponsor ID
- I-APT / SMC 2025-08-014
- Conditions
- Cancer
- Keywords
- Immunotherapy, Radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 2 Feb 2026 (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 find out whether Adaptive Pulse Radiotherapy (Pulse RT) combined with immune checkpoint inhibitors (ICIs) helps treat advanced solid tumors.
It will also check how safe this combined treatment is and how it affects the immune system and quality of life.
The main questions the study will try to answer are:
Does adding Pulse RT to ICIs improve tumor response and survival? What side effects occur when participants receive Pulse RT with ICIs? How does the treatment change immune-related blood and tissue markers? Does the treatment affect participants' quality of life?
Researchers will compare this new approach to usual ICI treatment to see whether Pulse RT makes a difference.
Participants will:
Continue to receive their standard ICI treatment. Receive 2-3 sessions of high-dose Pulse RT (8-10 Gy each) given about every 3 weeks.
Have the treatment volume adjusted based on how their tumors respond. Visit the clinic regularly for check-ups, imaging, blood tests, and quality-of-life questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulse RT | Experimental | Radiation: Pulse radiation therapy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Histologically confirmed solid tumor (radiologic diagnosis allowed for hepatocellular carcinoma)
- Currently receiving or planned to receive immune checkpoint inhibitor (ICI) therapy
- Presence of at least one lesion suitable for radiotherapy and measurable disease per RECIST version 1.1
- Ability and willingness to provide written informed consent
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding women
- Presence of brain metastasis or leptomeningeal metastasis
- Prior radiotherapy to the intended treatment site
- Significant comorbid conditions that may interfere with study participation or treatment (e.g., uncontrolled infection, heart failure, arrhythmia, psychiatric disorder)
- Inability or unwillingness to comply with study procedures
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 |
|---|---|---|
| Pulse radiation therapyAdaptive Pulse Radiotherapy (Pulse RT) is a personalized radiotherapy strategy designed to enhance anti-tumor immunity when combined with immune checkpoint inhibitors (ICIs). Patients receive 2-3 fractions of 8-10 Gy at 3-4-week intervals, with adaptive modification of target volumes according to tumor response. This approach aims to induce repeated immunogenic cell death and expand tumor-specific T-cell repertoires, thereby amplifying the efficacy of concurrent immunotherapy while maintaining safety within standard dose constraints. Both photon and proton modalities may be used, depending on lesion location and clinical judgment. | Radiation | Pulse RT |
Primary outcome
Progression-Free Survival at 6 Months
Time frame: 6 months after first radiation therapy
Progression-free survival (PFS) is defined as the time from the start of Adaptive Pulse Radiotherapy (first radiation treatment) to the date of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.
6 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Local Recurrence-Free Survival (LRFS)
Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Overall Survival (OS)
Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Objective Response Rate (ORR)
Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
Immune Response Profiling and Biomarker Analysis
Time frame: Baseline, during treatment, 1 month after last radiation therapy
Change in Patient-Reported Quality of Life
Time frame: Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy
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 Oct 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulse radiation therapy in people with Cancer, run by Samsung Medical Center 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 5 inclusion and 6 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 Oct 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.
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 Nalee Kim, MD, PhD (82-2-3410-2612, nalee.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival at 6 Months (time frame: 6 months after first radiation therapy). 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 Oct 2026.