Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors

NCT07381231 | Recruiting Phase 2

• 2 other identifiers: SMC 2025-08-0142025-08-014
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Immunotherapy; Radiation therapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival at 6 Months

  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.

  6 months after first radiation therapy

Secondary Outcomes (6)

• Progression-Free Survival (PFS)

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

• Local Recurrence-Free Survival (LRFS)

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

• Overall Survival (OS)

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

• Objective Response Rate (ORR)

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

• Immune Response Profiling and Biomarker Analysis

  Baseline, during treatment, 1 month after last radiation therapy

Study Arms (1)

Pulse RT

EXPERIMENTAL

Radiation: Pulse radiation therapy

Interventions

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.

Pulse RT

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Nalee Kim, MD, PhD

CONTACT

82-2-3410-2612; nalee.kim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: February 2, 2026
• Study Start: September 26, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): September 30, 2031
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

KR (1)