Adaptive pulse radiotherapy added to immunotherapy for advanced solid tumors
A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
PHASE2 · Samsung Medical Center · NCT07381231
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center (other) |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07381231 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cancer, Immunotherapy, Radiation therapy