NCT05733156招募中不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Abscopal effect rate of low-dose radiotherapy lesions
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Abscopal effect rate of low-dose radiotherapy lesions
时间窗: 3 months after completion of radiotherapy
The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1
次要结局
- Abscopal effect rate of low-dose radiotherapy lesions(1, 6, and 12 months after completion of radiotherapy)
- Overall response rate(1, 3, 6, and 12 months after completion of radiotherapy)
- Overall survival rate(12 months after completion of radiotherapy)
- Adverse event(12 months after completion of radiotherapy)
- Immune cell subsets of peripheral blood and tissue samples(1 and 3 months after completion of radiotherapy)
- Progression-free survival rate(12 months after completion of radiotherapy)
研究者
Ah Ram Chang
Director of Radiation Oncology
Soonchunhyang University Hospital
研究点 (4)
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