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NCT Number: NCT07381231

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.

Recruiting

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Key information

Conditions

Cancer Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulse radiation therapy

Radiation

Adaptive Pulse Radiotherapy (Pulse RT) is a personalized radiotherapy strategy designed to enhance anti-tumor immunity when combined with immune checkpoint inhibitors (ICIs). Patients receive 2-3 fractions of 8-10 Gy at 3-4-week intervals, with adaptive modification of target volumes according to tumor response. This approach aims to induce repeated immunogenic cell death and expand tumor-specific T-cell repertoires, thereby amplifying the efficacy of concurrent immunotherapy while maintaining safety within standard dose constraints. Both photon and proton modalities may be used, depending on lesion location and clinical judgment.

Primary outcomes

  1. Progression-Free Survival at 6 Months

    Time frame: 6 months after first radiation therapy

    Progression-free survival (PFS) is defined as the time from the start of Adaptive Pulse Radiotherapy (first radiation treatment) to the date of disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy

    Progression-free survival (PFS) will be assessed using Kaplan-Meier analysis.

  2. Local Recurrence-Free Survival (LRFS)

    Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy

    Local recurrence-free survival (LRFS) is defined as the time from initiation of Adaptive Pulse Radiotherapy to local tumor recurrence within the irradiated field or death from any cause, whichever occurs first.

  3. Overall Survival (OS)

    Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy

    Overall survival (OS) is defined as the time from initiation of Adaptive Pulse Radiotherapy to death from any cause.

  4. Objective Response Rate (ORR)

    Time frame: 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy

    Objective response rate is defined as the proportion of participants achieving complete or partial response according to RECIST version 1.1 criteria.

  5. Immune Response Profiling and Biomarker Analysis

    Time frame: Baseline, during treatment, 1 month after last radiation therapy

    Changes in circulating immune biomarkers, including cytokine levels (e.g., IL-6, IL-8, IL-10, TNF-β, IFN-γ) and immune cell subsets (e.g., CD3, CD4, CD8, NK cells, regulatory T cells), will be assessed in peripheral blood samples collected at specified time points.

  6. Change in Patient-Reported Quality of Life

    Time frame: Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy

    Patient-reported outcomes will be evaluated using the PRO-CTCAE core set at baseline and during follow-up. Changes over time will be analyzed using linear mixed models to assess treatment-related symptom burden and overall quality of life trends.

Study contacts

Contact information is provided by the study sponsor or research team.

Nalee Kim, MD, PhD

CONTACT

[email protected]

82-2-3410-2612

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: I-APT

Important dates

Study start
2025
Primary completion
2028
Study completion
2031
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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