Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy

Официальное название

Abscopal Effect from the Addition of Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)

Обзор

Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.

Вмешательства

• Лучевая терапия SBRT + LDRT
  Stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, and patients are treated with LDRT along with SBRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT.

Первичные конечные точки

• Abscopal effect rate of low-dose radiotherapy lesions [Срок оценки: 3 months after completion of radiotherapy]

Вторичные конечные точки (6)

• Abscopal effect rate of low-dose radiotherapy lesions [Срок оценки: 1, 6, and 12 months after completion of radiotherapy]
• Overall response rate [Срок оценки: 1, 3, 6, and 12 months after completion of radiotherapy]
• Progression-free survival rate [Срок оценки: 12 months after completion of radiotherapy]
• Overall survival rate [Срок оценки: 12 months after completion of radiotherapy]
• Adverse event [Срок оценки: 12 months after completion of radiotherapy]
• Immune cell subsets of peripheral blood and tissue samples [Срок оценки: 1 and 3 months after completion of radiotherapy]

Критерии участия

Критерии включения

• Patients who can provide their written informed consent
• Age ≥19 years
• Patients with histologically confirmed primary solid (irrespective of the status of the primary tumor)
• Patients with ECOG performance status 0-2
• Patients planning stereotactic body radiotherapy (three fractions) for extracranial metastases
• Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
• Patients with one or more measurable lesions, which are not suitable for SBRT or palliative radiotherapy and can be considered for LDRT (bone metastasis is not indicated for LDRT)
• Patients with hematologic function suitable for radiotherapy (absolute neutrophil count ≥1,500/mm\^3, hemoglobin ≥9 g/dL, platelet count ≥100,000/mm\^3)
• Patients with a life expectancy of 6 months or more according to the researcher's judgment

Критерии исключения

• Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study
• Patients with brain metastasis
• Patients planning SBRT for all measurable lesions due to oligometastasis
• Patients with a history of radiotherapy for extracranial metastases within 3 months of the enrollment
• Patients unable to cooperate with stereotactic body radiotherapy
• Patients who are pregnant or planning to
• Patients with advanced or multiple malignancies requiring aggressive treatment (excluding skin cancers other than melanoma or intraepithelial cancer)
• Patients who have received systemic steroid therapy or immunosuppressive therapy within 2 weeks of enrollment - Patients with an (e.g. allergic disease, radiation pneumonitis, etc.) (The use of steroids for preventive purposes is allowed (e.g., to prevent vomiting during chemotherapy)) active autoimmune disease requiring systemic treatment within the past 2 years, evidence of clinically severe autoimmune disease, or syndrome requiring systemic steroid or immunosuppressive therapy (Patients who need intermittent use of bronchodilators, inhaled steroids, or topical steroid injections, hypothyroid patients on stable hormone replacement therapy, type 1 diabetes patients, or patients recovering from childhood asthma/atopic dermatitis are permitted)
• Patients with active infection requiring systemic treatment

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 2 центра

• Seoul Metropolitan Government Seoul National University Boramae Medical Center — Seoul
• Soonchunhyang University Seoul Hospital — Seoul

Публикации

• Li H, Kwon J, Kim HJ, Kim BH. Immune-modulatory effects of low-dose radiotherapy through macrophage polarization and transcriptional rewiring in triple-negative breast cancer. Biochem Biophys Res Commun. 2025 Oct 30;786:152711. doi: 10.1016/j.bbrc.2025.152711. Epub 2025 Sep 26. PMID 41046657

Идентификаторы

NCT: NCT05733156 · SCHUH 2022-10-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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