Efficiency and Safety of Radiotherapy Combined With Anlotinib in Locally Advanced Non-small Cell Lung Cancer Patients Intolerable to Concurrent Chemoradiotherapy: A Phase II Single-arm Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 2-year progression-free survival (PFS)
研究概览
简要总结
Concurrent chemoradiotherapy (cCRT) is the standard treatment for patients with negative epidermal growth factor receptor (EGFR)-mutated unresectable locally advanced non-small cell lung cancer (LA-NSCLC). However, parts of patients only receive sequential chemoradiotherapy (sCRT) due to various reasons. This phase II study aimed to improve the outcomes of patients receiving sCRT by combining anti-angiogenesis therapy (Anlotinib) during radiotherapy course.We hypothesize that the combination of radiotherapy with anlotinib could improve the 2-year PFS rate from 35% with sCRT to 50. The accrual target was 44 patients.
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
- •≥18 years old with no restrictions on sex;
- •Peripheral tumor, or central lung cancer with non-squamous tissue or a mixed tissue with less than 50% squamous carcinoma;
- •Eastern cooperative oncology group (ECOG) score ≤2 was required;
- •Received systemic chemotherapy or combined chemotherapy and immumitherapy for ≥ 4 weeks without progression;
- •.No cavity inside the tumor, and located ≥ 1 cm of the main pulmonary artery trunk;
- •No symptoms of hemoptysis;
- •Adequate hepatic and renal functions with a negative urine protein;
- •Expected survival of more than 6 months.
排除标准
- •currently receiving treatment for malignancies at other sites, except for curable non-melanoma skin cancer and cervical carcinoma in situ;
- •previous malignancy within five years;
- •thoracic radiotherapy history, hemoptysis, myocardial infarction or cerebrovascular accident within three months;
- •uncontrolled or active pulmonary inflammation;
- •participated in other clinical trials;
- •Pregnant women.
研究组 & 干预措施
Radiotherapy plus Anlotinib
Radiotherapy plus anlotinib in LA-NSCLC intolerable to cCRT
干预措施: Anlotinib (Drug)
结局指标
主要结局
2-year progression-free survival (PFS)
时间窗: From the first day of radiotherapy to the occurrence of objective tumor progression or death due to any cause, whichever occurs first, assessed up to 60 months
次要结局
- Acute toxicity(From the first day of radiotherapy and up to the 3-month post-radiotherapy follow-up visit)
- Overall Survival(OS)(From the first day of radiotherapy to the occurrence of death due to any cause, assessed up to 60 months)
- Local regional recurrence (LR)(From the first day of radiotherapy to the occurrence of clinical and/or biopsy-proven recurrence within the bronchial stump, ipsilateral hilum, mediastinum, or supraclavicular, whichever occurs first, assessed up to 60 months)
- Distant metastasis (DM)(From the first day of radiotherapy to the occurrence of any evidence of metastatic disease beyond the locoregional regions previously mentioned, assessed up to 60 months)
研究者
JIANYANG WANG
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences