A Phase II Study of Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab in Unresectable, Locally Advanced Lung Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Resectability rate
研究概览
简要总结
The prognosis of patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) is poor. Chemoradiotherapy is the main treatment modality for this disease. The newer drug regimens can be expected to improve survival in this subset of NSCLC patients. Modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced NSCLC. Among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (VEGF). Bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. It allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. Thus, survival of these patients may be improved.
详细描述
This trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed unresectable, locally advanced (III A (bulky N2), III B) lung adenocarcinoma
- •No previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer
- •Adequate organ and bone marrow function
排除标准
- •Prior chemotherapy or radiation therapy for NSCLC
- •Prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (VEGF)
- •Patients with known hypersensitivity to other recombinant human antibodies
- •History of stroke or transient ischemic attack (TIA).
- •History of myocardial infarction or unstable angina within the past 12 months.
- •Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection.
- •Women who are pregnant or breast-feeding
研究组 & 干预措施
Neoadjuvant Bevacizumab
Four cycles of neoadjuvant chemotherapy with pemetrexed, carboplatin and bevacizumab.
干预措施: Neoadjuvant Bevacizumab (Drug)
结局指标
主要结局
Resectability rate
时间窗: 3 months
次要结局
- Number of participants with perioperative complications(4 months)
- Overall survival(2 years)
- Disease-free survival(2 years)
研究者
Si-Yu Wang
Professor
Sun Yat-sen University