NCT03403452Unknown2 期
A Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed After Standard Second Line Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- PFS（progress free survival）
研究概览
简要总结
This is an Exploratory Clinical Trial Study on Apatinib in the Treatment of Metastatic Colorectal Cancer Who Have Progressed after Standard Second Line Therapy.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 and ≤ 80 years of age
- •Histological confirmed advanced or metastatic colorectal cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT
- •Have failed for ≥ 2 lines of chemotherapy and/or targeted therapy
- •Life expectancy of more than 3 months
- •ECOG performance scale 0～1
- •Duration from the last therapy is more than 4 weeks for operation, radiotherapy or cytotoxic agents
- •Adequate hepatic, renal, heart, and hematologic functions (platelets > 80 ×10^9/L, neutrophil > 1.5 × 10^9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin < 1.5 ULN, and serum transaminase ≤ 2.0× ULN)
- •Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
- •Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
排除标准
- •Prior VEGFR inhibitor treatment within 2 weeks
- •History of other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy
- •More than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
- •Pregnant or lactating women
- •Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
- •URT: urine protein ≥ (++)and > 1.0 g of 24 h
- •PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation
- •Certain possibility of gastric or intestine hemorrhage
研究组 & 干预措施
arm for Apatinib
Experimental
500 mg,p.o.,qd
干预措施: Apatinib (Drug)
结局指标
主要结局
PFS（progress free survival）
时间窗: From assignment of the first subject to 3 months later after the last participant is recruited
PFS was defined as the time from assignment to disease progression radiological/clinical or death due to any cause
次要结局
- OS（overall survival）(From assignment of the first subject until 30 death events observed, up to 2 years)
- ORR（objective response rate）(From assignment of the first subject to 3 months later after the last participant is recruited)
- DCR（disease control rate)(From assignment of the first subject to 3 months later after the last participant is recruited)
研究者
Xu jianmin
Director of colorectal surgery
Fudan University
研究点 (1)
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