Phase II Study of Nab-paclitaxel Plus S-1 in First-line Treatment of Advanced Biliary Tract Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- objective response rate（ORR）
研究概览
简要总结
Advanced biliary tract adenocarcinoma has a poor prognosis with limited therapeutic options. Nab-paclitaxel plus S-1 chemotherapy will be given to untreated patients with advanced biliary tract adenocarcinoma for the first-line treatment.
详细描述
Gemcitabine/Nab-paclitaxel has become a standard therapy in advanced pancreatic cancer. Given the morphologic and histologic similarities between pancreatic cancer and biliary tract adenocarcinoma, nab-Paclitaxel may be a promising regimen, and S-1 has been approved for biliary tract cancer in Japan. Untreated patients with advanced biliary tract adenocarcinoma will receive Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w) as the first-line treatment. The investigators will investigate the efficacy and safety of the combination treatment, and expect to provide a more effective treatment plan for patients with advanced biliary tract cancer in China.The primary endpoint is objective response rate(ORR), and the secondary endpoints are progression-free survival(PFS), overall survival(OS) and the safety.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, years: 18-70
- •Histologically and cytologically confirmed advanced biliary tract adenocarcinoma, unresectable, measurable lesions according to RECIST criteria; ECOG score of 0-1; life expectancy ≥12 weeks;
- •Untreated; more than 6 months after the last adjuvant chemotherapy (does not include taxanes and S1);
- •Laboratory examination within 14 days before entering the study should meet following requirements:
- •ANC ≥ 1.5 x 10^9/L; PLT ≥ 100 x 10^9/L; Hb ≥ 90g/L (9g/dL); AST, ALT ≤ 2.5 x ULN (with no liver metastasis), ≤ 5 x ULN（with liver metastasis); creatinine ≤ 1.5 x ULN; TBIL ≤ 1.5 x ULN
- •Both male and female subjects of potential fertility have to agree effective birth control during the entire study
- •Informed consent
排除标准
- •Concurrent other effective treatment (including radiotherapy)
- •Resectable patients
- •Allergy history to other drugs in the same class patients with pregnancy or lactation
- •Known severe internal medical diseases
- •Abnormal heart function or relevant history of myocardial infarction and severe arrhythmia
- •Immunocompromised patients, such as HIV positive
- •Uncontrollable mental illness
- •Other conditions the researchers considered ineligible for the study
研究组 & 干预措施
Nab-paclitaxel Plus S-1
Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) S-1 (40mg BID for body surface area<1.25 m2; 50mg BID for body surface area of 1.25-1.5m2; and 60mg BID for body surface area>1.5 m2; D1-14, q3w)
干预措施: Nab-paclitaxel,S-1 (Drug)
结局指标
主要结局
objective response rate（ORR）
时间窗: 6 month
Assessed by RESIST
次要结局
- safety profile: assessed by CTCAE v4.0(1 year)
- Progression free survival (PFS)(6 month)
- overall survival time (OS)(1 year)
研究者
Aiping Zhou
Chief physician
Chinese Academy of Medical Sciences