A Multicenter, Single-arm, Phase Ⅱ Clinical Trial of Apatinib Monotherapy in Elderly Patients With Advanced Gastric Cancer(GC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 5
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment.
详细描述
The trial is funded by Chinese Society of Clinical Oncology-Beijing Xisike Clinical Oncology Research Fundation. The trial is prepared to be registered on the clinicaltrail.gov.
Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participate in all steps of the trail, including the record of the data, which is compared by the investigators. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the staff of research and financial department of Affliated Hospital of Qinghai University.
Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
Source data verification: The investigators assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.
Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elderly patients (aged ≥ 60 years) with histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction;
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
- •Progression with or intolerance to one or more lines of chemotherapy;
- •At least one measurable lesion as defined by RECIST 1.1;
- •With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;
- •Can take apatinib orally;
- •Estimated life expectancy ≥ 3 months.
排除标准
- •Patients cannot take apatinib orally for any reason;
- •Patients with uncontrolled central nervous system (CNS) metastases;
- •Patients with massive hydrothorax or ascites;
- •Proteinuria 2+ or 24-hour urinary protein ≥ 1g;
- •Newly-happened traumatism or pathological fracture;
- •Estimated life expectancy ˂ 3 months;
- •Received chemotherapy in the past 28 days before enrollment;
- •Patients with uncontrolled blood pressure on medication (≥ 140/90 mmHg);
- •Patients with bleeding tendency, receiving thrombolytics or anticoagulants, receiving intravenous antibiotic treatment, had received bevacizumab or other VEGF TKIs before, or with other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ).
研究组 & 干预措施
Apatinib Group
take apatinib orally (500mg/d or 250mg/d, once a day, continuously )
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: 1 year
PFS was defined to be the time from registration to the date of disease progress sion or death resulting from any cause.
次要结局
- Disease control rate (DCR)(1 year)
- Overall survival (OS)(1 year)
- Objective response rate (ORR)(1 year)
研究者
Jiuda Zhao
Professor
Affiliated Hospital of Qinghai University