A Prospective Phase II Study of Immunotherapy With Adaptive Pulse Radiotherapy in Solid Tumors
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Progression-Free Survival at 6 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •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
排除标准
- •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
研究组 & 干预措施
Pulse RT
干预措施: Pulse radiation therapy (Radiation)
结局指标
主要结局
Progression-Free Survival at 6 Months
时间窗: 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.
次要结局
- 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)
- Change in Patient-Reported Quality of Life(Baseline, During treatment, 3, 6, 12, 24, and 36 months after initiation of Adaptive Pulse Radiotherapy)
研究者
Nalee Kim
Assistant professor
Samsung Medical Center