NCT07381231 Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
| NCT ID | NCT07381231 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Samsung Medical Center |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-09-26 |
| Primary Completion | 2028-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 35 participants in total. It began in 2025-09-26 with a primary completion date of 2028-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381231 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07381231 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07381231 currently recruiting?
Yes, NCT07381231 is actively recruiting participants. Contact the research team at nalee.kim@samsung.com for enrollment information.
Where is the NCT07381231 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07381231 clinical trial?
NCT07381231 is sponsored by Samsung Medical Center. The trial plans to enroll 35 participants.
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