Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated With Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy：an Open Label, Single Arm Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- 1-year progression-free survival
研究概览
简要总结
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy
详细描述
This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between18 years and 80 years at time of study entry
- •ECOG performance status of 0 or 1
- •Body weight >30 kg
- •Adequate bone marrow, liver and kidney function
- •Life expectancy of at least 3 months
- •At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
- •Histologic or cytologic confirmation of small cell lung cancer
- •Stage III-IV disease (TNM v8)
- •Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value
- •Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -
排除标准
- •Previous chemo-, immuno- or radiotherapy for SCLC
- •Major surgical procedure last 28 days
- •History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- •Uncontrolled intercurrent illness
- •Other active malignancy
- •Leptomeningeal carcinomatosis
- •Immunosuppressive medication
- •Pregnant or breastfeeding women
研究组 & 干预措施
experimental group
chemo-immunotherapy followed by thoracic radiotherapy and PD-1/PD-L1 maintenance therapy
干预措施: thoracic radiotherapy (Radiation)
结局指标
主要结局
1-year progression-free survival
时间窗: 12 months after last patient entry
PFS is defined as the period from the start of receiving the first EC/EP chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
次要结局
- 1-year overall survival(12 months after last patient entry)
- 5-year overall survival(5-year after last patient entry)
- toxicities(12 months after last patient entry)