Toripalimab Combined With S1 and Albumin Paclitaxel as First Line in Patients With Advanced Biliary Tract Cancer: a Single-arm,One Center， Phase II Clinical Study
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
- objective response rate
研究概览
简要总结
The investigator's study is a single armed phrase II trial ,aiming to improve the effecacy of treatment for advanced billiary tract cancer by means of Toripalimab combining with S1 and Albumin Paclitaxel as first line in patients with advanced Biliary Tract Cancer. treatment continually until disease progression or intolerable toxicity or Patients withdrawal of consent.and target sample is 30+ patients.
详细描述
Toripalimab: 240 mg , once every 2-3 weeks; S1: 80-120mg, bid; oral, day1-14; Albumin paclitaxel: 120mg/m2 , administered on the first day and the eighth day of each cycle; 21 days for a treatment cycle
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
- •Age ≥ 18 years old
- •Patients with gallbladder and cholangiocarcinoma diagnosed by histology or cytology
- •Liver function Child-Pugh grade A (5-6 points) or better grade B (≤ 7 points)
- •ECOG score 0 or 1 point
- •At least one measurable lesion
- •no previous treatment
排除标准
- •organs failure ,including liver ,heart ,kidney
- •Have received a liver transplant in the past
- •Active brain metastasis or spinal cord compression
- •ECOG score 3 or 4 point
- •Symptomatic peripheral neuropathy (CTCAE ≥ 2)
研究组 & 干预措施
Toripalimab Combined With S1 and Albumin Paclitaxel
干预措施: Toripalimab Combined With S1 and Albumin Paclitaxel (Drug)
结局指标
主要结局
objective response rate
时间窗: 1 year
ORR
次要结局
- progression free survival(1 year)
- disease response rate(1 year)
- overall survival(1 year)
研究者
Dai, Guanghai
professor,deputy cheif of oncology department
Chinese PLA General Hospital