NCT03521219Unknown2 期
Single Arm, Exploratory and Open Clinical Trial of Second-line Therapy With Apatinib Mesylate in Advanced Cholangiocarcinoma
The First Affiliated Hospital of Zhengzhou University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年2月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Disease Control Rate (DCR)
研究概览
简要总结
The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18-65 years;
- •Eastern Cooperative Oncology Group performance score (ECOG): 0-2;
- •Estimated survival time > 3 months;
- •Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis;
- •Previous first-line GP programmes failed, or were not able to withstand first-line treatment;
- •At least one measurable lesion [spiral CT scan ≥ 10 mm (CT scan thickness not greater than 5mm)], Measurable lesions were not treated with radiotherapy or other topical treatments unless progress was achieved after treatment was completed (RECIST version 1.1);
- •Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, HB ≥ 8 g/dL,ALB ≥2.8g/dL，TBIL ≤ 3×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Cr clearance ≥ 50 mL/min;Thyroid function is normal；
- •No serious history of drug allergy；
- •Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up.
排除标准
- •Patients have received targeted therapy；
- •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)；
- •Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment；
- •Urine routine showed that urine protein ≥++ or the urine protein in 24 hours>1.0 g；
- •Pregnant or lactating women；
- •History of other malignancy within 5 years except for effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma and / or effectively excised orthotopic cervical and / or breast cancer;
- •The researchers judged other conditions that might affect clinical research and the outcome of the study.
研究组 & 干预措施
Apatinib
Experimental
Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
干预措施: Apatinib (Drug)
结局指标
主要结局
Disease Control Rate (DCR)
时间窗: 1 month
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
次要结局
- Overall Survival(36 month)
- Progression-free Survival(24 month)
- Objective Response Rate(ORR)(1 month, 3 month, 6 month)
研究者
Wei He
Deputy Chief Physician of Oncology
The First Affiliated Hospital of Zhengzhou University
研究点 (1)
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