A Phase I Clinical Study to Explore the Safety and Efficacy of Hypervision Proton Surgery (HyPROS) for Early-stage Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The incidence of grade ≥ 3 psAEs at 1 month
研究概览
简要总结
This study was a single-center, single-arm clinical study to evaluate the safety and efficacy of hypervision proton surgery with single large fractionated doses (34GyE and 39GyE) in the treatment of early peripheral NSCLC.
详细描述
This study adopted a dose escalation protocol (an improved "two-stage two-dose group" design) to explore the safety and efficacy of visual proton surgery (single large fractionated doses of 34GyE and 39GyE) in the treatment of early peripheral NSCLC.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be at least 18 years old
- •Karnofsky Performance Status > 80
- •NSCLC confirmed by cytology or histology; for subjects who cannot safely obtain pathological evidence due to factors such as tumor lesion location, patient's underlying diseases, or high puncture risk, after unanimous consent of the multidisciplinary team (MDT) discussion, they meet the clinical diagnostic criteria for NSCLC based on typical imaging features (such as enhanced chest CT and/or PET/CT) combined with clinical manifestations;
- •Early-stage tumors are defined as T1 (≤3cm) N0M0 based on enhanced computed tomography (CT) and positron emission tomography (PET)
- •The tumor must be more than 2 cm away from the proximal bronchial tree in all directions (the proximal bronchial tree is defined as 2 cm from the distal end of the trachea, the protrusion and the named lobar bronchus up to its first bifurcation)
- •FEV1 ≥ 1 L, FEV1 ≥ 40% of the predicted value (either one is sufficient); DLCO ≥ 40% of the predicted value
- •The patient can tolerate PET-CT examination
- •For female study participants of childbearing age, the urine or serum pregnancy test was negative within 7 days prior to the first administration of the study drug. If the result of the urine pregnancy test is positive, a blood pregnancy test is required
排除标准
- •Other malignant tumors occurred concurrently within 2 years before enrollment
- •A history of chest radiotherapy in the past
- •It is planned to use other anti-tumor treatments within the regimen treatment (within 4 weeks)
研究组 & 干预措施
Proton radiotherpy
Proton radiotherapy 34GyE/f or 39GyE/f
干预措施: Hypervision proton surgery (Radiation)
结局指标
主要结局
The incidence of grade ≥ 3 psAEs at 1 month
时间窗: 1 month after proton radiotherapy
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
The incidence of grade ≥ 3 psAEs at 1 year
时间窗: 1 year after proton radiotherapy
Radiation induced adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE)
次要结局
- Primary tumor control at 1 year(1 year after proton radiotherapy)
- Disease-free survival time(From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months)
- Overall survival time(From date of treatment until the date of death)
研究者
Shuanghu Yuan
Professor
Anhui Provincial Hospital