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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-08-014 | Other Identifier | Samsung medical center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pulse RT | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse radiation therapy | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after first radiation therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | Progression-free survival (PFS) will be assessed using Kaplan-Meier analysis. | 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy |
| Local Recurrence-Free Survival (LRFS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nalee Kim, MD, PhD | Contact | 82-2-3410-2612 | nalee.kim@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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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.
| 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. | 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. | 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. | 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. | Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy |