Real-world Study of Prophylactic Cranial Irradiation After Immunotherapy Combined With Chemotherapy for Extensive-stage Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Progression-free survival in the brain
研究概览
简要总结
The prognosis of extensive-stage small cell lung cancer is still very poor, even for those who received chemotherapy and immunotherapy. This experimental study is a real-world research design to evaluate the effectiveness and safety of prophylactic cranial irradiation in patients with extensive-stage small cell lung cancer who with first-line chemotherapy combined with immunotherapy.
详细描述
This study is a prospective trial. This study included ES-SCLC patients who response after standard first-line treatment, and aimed to explore the safety and effectiveness of prophylactic cranial irradiation in this treatment modality.
The primary endpoint is progression-free survival in the brain.The secondary endpoints includes OS, PFS. The indicators for evaluating safety are the incidence and severity of adverse events.The exploratory endpoint is the molecular biomarkers for efficacy and toxicity predicting from tumor tissue and peripheral blood TMB.
The trial was designed by the National Cancer Center/Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College. The hypothesis is that preventive brain irradiation is safe and effective in the treatment of extensive SCLC combined with chemotherapy and immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Sign written informed consent;
- •With extensive small cell lung cancer;
- •Previously received first-line standard chemotherapy, with treatment response of CR or PR;
- •Can tolerate the radiotherapy process;
- •Be over 18 years old
- •Life expectancy ≥ 12 weeks;
- •With the Eastern Cancer Cooperative Group (ECOG) score 0-1
- •After the systemic treatment was received, there was no brain metastasis on MR before brain preventive irradiation.
排除标准
- •Exclude subjects with central nervous system (CNS) metastasis at the first diagnosis;
- •Pregnancy or breastfeeding;
- •Any other conclusive medical, psychiatric and/or social reasons determined by the researcher;
- •Subjects who have previously suffered from other malignant tumors (excluding non-melanoma skin cancer and the following carcinoma in situ: bladder, stomach, colon, endometrial, cervical/dysplasia, melanoma or breast cancer) are not allowed to participate in the study. Unless he/she has been in complete remission at least 2 years before enrolling in the study, and does not need to receive other treatments or does not need to receive other treatments during the study;
- •Researchers believe that the treatment methods used in the study can cause harm or cause basic diseases whose toxicity is difficult to judge when judging adverse events.
结局指标
主要结局
Progression-free survival in the brain
时间窗: 1 year
The length of time during and after treatment for a disease in which the patient lives with the disease but the intracranial lesions do not worsen
次要结局
- Progression-free survival (PFS)(1 year)
- Overall survival (OS)(1 year)
- Adverse events(1 year)
- The cognitive function of the patient(1 year)
研究者
Luhua Wang
Professor
Chinese Academy of Medical Sciences