NCT03144856Unknown2 期
Phase II Study of Apatinib as Second Line Therapy in Patients With Advanced Refractory Biliary Tract Cancer
Sun Yat-sen University2 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2017年2月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 39
- 试验地点
- 2
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This study is designed to see whether Apatinib is effective in treating patients with advanced refractory biliary tract cancers.
详细描述
Biliary tract cancers (BTC) includes cholangiocarcinoma and gallbladder carcinoma (GBC). The systematic treatment based on gemcitabine plus cisplatin is recommended as the current standard chemotherapy for unresectable or metastatic BTC. There is no standard recommendation for second line therapy.
Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor 2(VEGFR-2).
This study was conducted to assess the efficacy and safety of Apatinib in patients with advanced refractory BTC who had received first-line chemotherapy.
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
- •Must have histologically or cytologically documented carcinoma primary to the intra- or extra-hepatic biliary system or gall bladder with clinical and/or radiologic evidence of unresectable, locally advanced or metastatic disease.
- •Patients with ampullary carcinoma are not eligible.
- •Must have failed or are intolerant to one line of systemic treatment but no more than 2 prior lines of systemic chemotherapy for advanced BTC. Patients who received adjuvant chemotherapy and had evidence of disease recurrence within 6 months of completion of the adjuvant treatment are also eligible. If the patient received adjuvant treatment and had disease recurrence after 6 months, patients will only be eligible after failing or having intolerance to one line of systemic chemotherapy used to treat the disease recurrence.
- •Age between 18 and 75 years old
- •Eastern Cooperative Oncology Group (ECOG) Performance Status Assessment of 0 or
- •Must have radiographic measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Life expectancy of at least 12 weeks (3 months).
- •For patients who have received prior radiation, cryotherapy, radiofrequency ablation, therasphere, ethanol injection, transarterial chemoembolization (TACE) or photodynamic therapy, the following criteria must be met: 28 days have elapsed since that therapy; Lesions that have not been treated with local therapy must be present and measureable.
- •Must be able to understand and be willing to sign the written informed consent form. Must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.
- •All acute toxic effects of any prior treatment have resolved to NCI-CTCAE v4.0 Grade 1 or less at the time of signing the Informed Consent Form (ICF) except for alopecia.
- •Adequate bone marrow, liver and liver function.
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug.
- •Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the ICF until at least 3 months after the last dose of study drug.
排除标准
- •Pregnant or lactating women;
- •History of other malignancies except cured basal cell carcinoma of skin and carcinoma insitu of uterine cervix;
- •Uncontrolled hypertension;
- •Intercurrence with one of the following: coronary artery disease, arrhythmia and heart failure;
- •Urine protein>grade 1;
- •Any factors that influence the usage of oral administration;
- •Patients with a clear tendency of gastrointestinal bleeding;
- •Abnormal coagulation function(INR≥1.5, APTT≥1.5 ULN);
- •Abuse of alcohol or drugs;
- •Less than 4 weeks from the last clinical trial;
- •Prior treatment with antivascular endothelial growth factor or the other anti angiogenesis therapy;
- •Active central nervous system (CNS). If CNS metastases are treated and potential participants are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment.
- •Disability of serious uncontrolled intercurrence infection.
研究组 & 干预措施
Apatinib group
Experimental
Apatinib 500mg, po, QD, every 4 weeks.
干预措施: Apatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Approximately 1 year
the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy
次要结局
- Overall survival (OS)(Approximately 2 years)
- Disease control rate(DCR)(Approximately 1 year)
- Quality of life(QoL)(Approximately 1 year)
- Safety (incidence of adverse events)(Approximately 1 year)
研究者
Fenghua Wang
Professor
Sun Yat-sen University
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Maintenance Treatment of Apatinib in Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT03130270Guilin Medical University, China29
Unknown
2 期
Afatinib in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification (ESCC-A01)Esophageal Squamous Cell CarcinomaNCT03940976Peking University40
Unknown
2 期
Adjuvant Therapy With Apatinib for HCC Patients With PVTT Who Underwent Radical ResectionCarcinoma, HepatocellularNCT03261791Shanghai Zhongshan Hospital30
Unknown
2 期
Clinical Study of Apatinib as the Second-line Therapy in Malignant MelanomaMalignant MelanomaNCT03383237Henan Cancer Hospital20
Unknown
2 期
Apatinib for Advanced Biliary CarcinomaBiliary Tract NeoplasmsNCT03427242Fudan University55