NCT04313660Unknown2 期
Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
Xiaorong Dong0 个研究点目标入组 33 人开始时间: 2020年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 33
- 主要终点
- progress free survival(PFS)
研究概览
简要总结
Anlotinib In Combination With PD-1/L1 Inhibitor As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up;
- •Patients between 18-75 years old;
- •Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide [complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard];
- •The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks;
- •The life expectancy shall be at least 3 months;
- •ECoG score: 0-1
排除标准
- •Small cell lung cancer patients with other pathological types of tumor species;
- •Patients with pathological fracture in bone metastasis of small cell lung cancer;
- •Patients with central nervous system metastasis;
- •Patients who have received chest radiotherapy before;
- •Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before;
- •Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;
研究组 & 干预措施
Anlotinib In Combination With PD-1/L1 Inhibitor
Experimental
干预措施: Anlotinib In Combination With PD-1/L1 Inhibitor (Drug)
结局指标
主要结局
progress free survival(PFS)
时间窗: 1 year
the period from the beginning of treatment to the observation of disease progress or death for any reason
次要结局
- Overall survival(OS)(1 year)
研究者
Xiaorong Dong
Professor
Wuhan Union Hospital, China
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