Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Pulse radiation therapy.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
Overview
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
- Radiation Pulse 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 s
Primary outcome measures
- Progression-Free Survival at 6 Months [Time frame: 6 months after first radiation therapy]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Samsung medical center — Seoul
Identifiers
NCT: NCT07381231 · SMC 2025-08-014 · 2025-08-014