NCT03251443已完成2 期
Single Center, Single Arm, Open Study, to Explore and Evaluate Treatment of Apatinib in Patients With Advanced Intrahepatic Cholangiocarcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
The purpose of this study is to explore the efficacy and safety of second-line treatment of apatinib in advanced intrahepatic cholangiocarcinoma patients and evaluate drug safety, progression free and overall survival. The primary endpoint of this study is objective response rate (ORR), disease control rate (DCR) and progression-free survival (PFS).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV;
- •Have progressed after systematic chemotherapy/target therapy, or cannot tolerated with first-line treatment;
- •The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment;
- •Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
- •Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
- •Life expectancy of at least 12 weeks;
- •Subjects who understand and voluntarily signed a written informed consent form.
排除标准
- •Previous locoregional therapy within 4 weeks prior to enrollment.
- •Diagnosed with hepatocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma.
- •History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma.
- •Prepared for liver transplantation.
- •Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction).
- •A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence.
- •Use of CYP3A4 inhibitor within 7 days or CYP3A4 inducer within 12 days prior to enrollment.
- •Patients with central nervous system metastases or brain metastasis
- •Previous definite diagnosis of neuropsychiatric disturbances, including epilepsy or dementia.
- •Pregnant or lactating women.
- •Patients with bone metastasis received palliative radiation within 4 weeks prior to enrollment.
研究组 & 干预措施
Apatinib
Experimental
A molecular targeted anti-tumor drugs. Small molecule vascular endothelial growth factor receptor 2 inhibitor.
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: six months
A duration from the date of initial treatment with apatinib to disease progression (as defined by RECIST) or death.
Objective Response Rate (ORR)
时间窗: one year
Disease Control Rate (DCR)
时间窗: one year
次要结局
- Overall Survival (OS)(two years)
- Incidence of Treatment-Emergent Adverse Event(one year)
研究者
研究点 (1)
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