Adaptive pulse radiotherapy added to immunotherapy for advanced solid tumors
Official title: A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
Run by Samsung Medical Center · NCT07381231 · Data updated 2026-11-12
This trial will test whether adding adaptive pulse radiotherapy to immune checkpoint inhibitors helps people with advanced solid tumors respond better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 45 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | September 26, 2025 |
| Main results expected | September 30, 2028 |
| Study ends | September 30, 2031 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07381231 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with histologically confirmed solid tumors who have ECOG 0–2, are receiving or planned to receive immune checkpoint inhibitors, and have at least one lesion suitable for radiotherapy and measurable by RECIST 1.1.
✕Probably not a fit
Patients with brain or leptomeningeal metastases, prior radiation to the intended treatment site, uncontrolled major comorbidities, or who are pregnant or breastfeeding are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, single-center interventional trial adds adaptive Pulse RT to participants' ongoing immune checkpoint inhibitor therapy for advanced solid tumors. Participants receive 2–3 high-dose pulse radiotherapy sessions (8–10 Gy each) about every three weeks, with the treated volume adjusted based on tumor response. Researchers will compare outcomes to standard ICI treatment and monitor tumor response, survival, safety, immune-related blood and tissue markers, and quality of life with regular clinic visits and imaging. Key exclusions include brain or leptomeningeal metastases, prior radiation to the intended site, pregnancy, and significant uncontrolled comorbidities.
Why it matters
Potential benefit: If successful, this approach could increase tumor responses and survival by enhancing the immune effect of checkpoint inhibitors with targeted high-dose radiation.
How similar studies have gone: Previous trials combining radiation with immune checkpoint inhibitors have shown promising signals in some cancers, but adaptive pulse radiotherapy as a specific technique is relatively novel and not yet proven in large randomized studies.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Samsung medical center
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Nalee Kim, MD, PhD
- Email: nalee.kim@samsung.com
- Phone: 82-2-3410-2612
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.