A Phase II, Single-arm, Open-label, Multicenter Study to Assess the Efficacy and Safety of Surufatinib as a Second-line Treatment in Patients With Surgically Unresectable or Metastatic Biliary Tract Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 5
- 主要终点
- Progression-free survival (PFS) rate at Week 16
研究概览
简要总结
A phase II, single-arm, open-label, multicenter study to assess the efficacy and safety of Surufatinib as a second-line treatment in patients with surgically unresectable or metastatic biliary tract carcinoma
详细描述
This study adopt Simon's two-stage designs method based on the primary endpoint of 16-week PFS rates. In the first stage, 16 patients will be recruited. If there are 3 or fewer patients without progression or death out of these 16 patients at week 16, the study will be stopped. Otherwise, 16 additional patients will be accrued for a total of 32 evaluable patients.
Surufatinib will be orally administered within 1 hour after breakfast once a day (QD) for every 28-day treatment cycle until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met (which comes first).
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
- •Provision of written Informed Consent Form (ICF) prior to any study specific procedures
- •Aged at least 18 years
- •Histologically or cytologically confirmed advanced BTC that was surgically unresectable or metastatic, including extrahepatic cholangiocarcinoma (EHCC), intrahepatic cholangiocarcinoma (IHCC) or gallbladder biliary carcinoma (GBC)
- •First-line prior treatment of cytotoxic chemotherapy, treatment failure or intolerable toxicities
- •Patients must have measurable lesions
排除标准
- •Anti-tumor therapy received within 4 weeks prior to initiation of study treatment
- •Previous therapy with approved or investigational anti-VEGF (or VEGFR) tyrosine kinase inhibitors or monoclonal antibody
- •Liver metastases ≥50% of liver volume
- •Child-Pugh classification score of liver function> 7
- •History or presence of a serious hemorrhage (>30 ml within 3 months), hemoptysis (>5 ml blood within 4 weeks) or a thromboembolic event (including transient ischemic attack and/or stroke events) within 12 months
- •Active malignancy (except for definitively treated basal or squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix) within the past 5 years
- •Patients receive CYP3A4 potent inducer or inhibitors within 2 weeks
- •Pregnancy ( positive pregnancy test before the first dose of study treatment) or lactating women
研究组 & 干预措施
Surufatinib
Surufatinib 300mg once-daily
干预措施: Surufatinib (Drug)
结局指标
主要结局
Progression-free survival (PFS) rate at Week 16
时间窗: Progression-free survival (PFS) rate at Week 16
Proportion of patients without PD or death at Week 16
次要结局
- Adverse events evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03(From first dose to within 30 days after the last dose)
- Clinically significant laboratory, vital sign or physical examination abnormalities, electrocardiogram (ECG) and echocardiogram changes(From first dose to within 30 days after the last dose)
- Objective response rate (ORR)(6 months after the last patient enrolled)
- Disease control rate (DCR)(6 months after the last patient enrolled)
- Progression-free survival (PFS)(6 months after the last patient enrolled)
- Overall survival (OS)(6 months after the last patient enrolled)
- Duration of response (DoR)(6 months after the last patient enrolled)