Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors (I-APT)

Samsung Medical Center

Status and phase: Enrolling; Phase 2

Conditions: Cancer

Treatments: Radiation: Pulse radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07381231

2025-08-014 (Other Identifier)

SMC 2025-08-014

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Pulse RT

Experimental group

Treatment:

Radiation: Pulse radiation therapy