Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors

A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors

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.

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