NCT02974933Unknown2 期
Apatinib Mesylate Combined With Pemetrexed in the Treatment of Pretreated Advanced Non-squamous Non-small Cell Lung Cancer ：Single Arm Exploratory Study
Wuling Ou1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年11月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of apatinib mesylate combined with pemetrexed alone in advanced non-small cell lung cancer patients in the second or second line of treatment of progression-free survival
详细描述
It is a one-arm study. The progression-free survival will be evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged from 18 years to 70years.
- •Histologically or cytologically confirmed non-squamous non-small cell lung cancer(stage IIIB/IV).
- •Measurable lesions as defined by RECIST criteria.
- •Locally advanced lung cancer cannot treat with surgery, recurrent or metastatic lung cancer
- •ECOG performance status (PS) of 0 to
- •Life expectancy ≥3 months.
- •Informed consent.
排除标准
- •Squamous carcinoma (including adeno-squamous carcinoma), small cell lung cancer.
- •Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
- •Tumor invade big vessels or close to big vessels (less than 5mm)
- •Obvious cavity or necrosis formed in the tumor
- •Uncontrolled hypertension
- •Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
- •Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy
- •The active HBV or HCV infection
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix.
- •Hemoptysis, more than 2.5ml daily
- •Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
- •Unhealed bone fracture or wound for long time
- •Received big surgery, had bone fracture or ulcer in 4 weeks.
- •Urine protein≥++, or urine protein in 24 hours≥1.0g
- •Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment
- •Have received prior treatment with VEGFR TKI (Bevacizumab is permitted).
- •Pregnant or lactating woman, or woman unwilling to practice contraception during the study.
研究组 & 干预措施
apatinib
Experimental
combined with pemetrexed
干预措施: Apatinib combined with pemetrexed (Drug)
结局指标
主要结局
progression free survival
时间窗: 4 weeks
evaluation per 28 days
次要结局
- Adverse Event(4 weeks)
- Overall Survival(4 weeks)
- disease control rate(4 weeks)
- objective response rate(4 weeks)
研究者
Wuling Ou
Deputy Chief Physician
Hubei Cancer Hospital
研究点 (1)
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