Cancer
Conditions
Keywords
Immunotherapy, Radiation therapy
Brief 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. 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.
Interventions
RADIATIONPulse radiation therapy
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.
Sponsors
Samsung Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy | Progression-free survival (PFS) will be assessed using Kaplan-Meier analysis. |
| Local Recurrence-Free Survival (LRFS) | 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy | 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. |
| Overall Survival (OS) | 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy | Overall survival (OS) is defined as the time from initiation of Adaptive Pulse Radiotherapy to death from any cause. |
| Objective Response Rate (ORR) | 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy | Objective response rate is defined as the proportion of participants achieving complete or partial response according to RECIST version 1.1 criteria. |
| Immune Response Profiling and Biomarker Analysis | Baseline, during treatment, 1 month after last radiation therapy | 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. |
| Change in Patient-Reported Quality of Life | Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy | 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. |
Countries
South Korea
Contacts
CONTACTNalee Kim, MD, PhD
Outcome results
None listed