A Study of Apatinib in Combination With Chemotherapy Versus Chemotherapy Alone for Advanced Ovarian Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- carcinoma antigen 125 (CA125)
研究概览
简要总结
The study is evaluated the effacy and safety of apatinib combined with chemotherapy in the advanced ovarian cancer
详细描述
Ovarian cancer and fallopian tube cancer are common gynecological malignancies in our country. Ovarian cancer ranks the second in the incidence of gynecologic malignancies. The mortality rate is the highest. The following three major characteristics exist: First, 70% of the patients are advanced patients; 70% of the patients Easy to relapse after treatment; Third, 5-year survival rate of about 30%, a serious threat to women's health. Our hospital ovarian cancer, tubal cancer patients because of regional constraints, the economy is poor, the more the past, the use of simple chemotherapy, relapse rate and mortality were higher.
In the latest National Comprehensive Cancer Network (NCCN) guidelines, bevacizumab plus CP is recommended for patients with stage II, III, and IV ovarian cancer and fallopian tube cancer, and clinical trials of new drugs are recommended for recurrent / metastatic ovarian cancer. Apatinib mesylate is a small molecule VEGFR tyrosine kinase inhibitor authored by Jiangsu Hengrui Pharmaceutical Co., Ltd., whose chemical name is N- [4- (Cyanocyclopentyl) phenylmethane sulfonate ] [2 - [(4-picolyl) amino] (3-pyridyl)] carboxamide of the formula C25H27N5O3S with a molecular weight of 493.58 (mesylate salt).Apatinib can effectively inhibit VEGFR-2 at a very low concentration, while higher concentrations can inhibit the action of apatinib, such as platelet-derived growth factor receptor (PDGFR), c-Kit and c- The site is the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamic studies show that apatinib can inhibit the VEGFR-2 tyrosine kinase activity, blocking VEGF signaling after binding, resulting in inhibition of tumor angiogenesis. Preclinical studies have shown that apatinib has a strong inhibitory effect on the growth of many human nude mice xenografts such as sarcoma, colorectal cancer, non-small cell lung cancer, gastric cancer and liver cancer and is a broad-spectrum anti-tumor drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Pathologically diagnosed as epithelial ovarian cancer, fallopian tube cancer, stage II-IV period, the expected survival of> 6 months;
- •ECOG <2;
- •Liver and kidney function is normal;
- •No uncontrollable high blood pressure, bleeding, perforation, obstruction.
排除标准
- •Serious cardiopulmonary insufficiency, can not tolerate chemotherapy;
- •Pregnant or lactating women;
- •3 years have occurred in other tumors (cervical cancer in situ, has cured basal cell carcinoma, except for bladder epithelial tumors);
- •Allergic to apatinib or its accessories.
研究组 & 干预措施
apatinib combine with chemotherapy
干预措施: Apatinib (Drug)
apatinib combine with chemotherapy
干预措施: Taxus + platinum (Drug)
chemotherapy
干预措施: Taxus + platinum (Drug)
结局指标
主要结局
carcinoma antigen 125 (CA125)
时间窗: 24month
Cancer antigen 125 (CA-125) is a protein found on the surface of many ovarian cancer cells. It also can be found in other cancers and in small amounts in normal tissue. A CA-125 test measures the amount of this protein in the blood.
PFS(Progress free survival)
时间窗: 24 month
he length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
次要结局
未报告次要终点
研究者
Zhang Xuan
M.D., head of the department of the obstetrics and gynecology
The People's Hospital of Leshan