Prospective study of Adaptive pulse radiotherapy and immunotherapy

A Prospective Phase II Study of Immunotherapy with Adaptive Pulse radiotherapy in Solid Tumors

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0011239

Enrollment

Registered

2025-12-02

Start date

2025-10-10

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Radiation : Radiotherapy modality: Both proton therapy and X-ray–based radiotherapy are included. Treatment timing: Radiotherapy will be administered between Immune checkpoint inhibitor dosing cycles

however, it will be omitted in cases with impaired renal function. Depending on the treatment site and clinical judgment, 4-dimensional computed tomography or magnetic resonance imaging simulation may

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0–2. Patients with histologically confirmed primary solid tumors (radiological diagnosis permitted for hepatocellular carcinoma). Patients who are currently receiving or are scheduled to receive immune checkpoint inhibitors (ICIs). Patients with at least one lesion deemed eligible for radiotherapy by the investigator and measurable disease according to RECIST version 1.1. Patients who voluntarily agree to participate in the study and provide written informed consent.

Exclusion criteria

Exclusion criteria: Female patients who are pregnant or breastfeeding. Patients with brain metastases or leptomeningeal metastases. Patients with a history of prior radiotherapy to the intended treatment site. Patients with serious comorbid conditions that may limit study participation or the administration of the investigational treatment, as determined by the investigator (e.g., uncontrolled infection, heart failure, arrhythmia, psychiatric disorders). Patients who are considered unable to comply with the requirements of the study protocol. Patients deemed inappropriate for study participation by the principal investigator or treating physician.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	—

Secondary

Measure	Time frame
Overall response rate;Local recurrence free survival;Overall survival;Dynamics in immune cells and biomarker;Dynamics in radiomic features based on CT;Patient-reported outcome	—

Countries

Korea, Republic of

Contacts

Public ContactNalee Kim

Samsung Medical Center

dotdd9002@naver.com+82-2-3410-2612

Outcome results