Randomized Phase II Trial of SP vs. GP in Advanced Biliary Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Progression-free survival rate at 6 months
研究概览
简要总结
To select a better agent between S-1 or gemcitabine in combination with cisplatin for the conventional chemotherapy platform for future development in advanced Biliary Tract Adenocarcinoma (BTA), the investigators conduct a randomized phase II trial of S-1 and cisplatin (SP) versus gemcitabine and cisplatin (GP) as first line therapy in advanced BTA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Pathologically proven biliary adenocarinoma
- •Evaluable disease
- •ECOG performance status of 2 or better
- •No prior exposure to chemotherapy, but adjuvant chemotherapy (or chemoradiotherapy) completed 6 moths or more before study enrollment is allowed
- •Adequate bone marrow function A. WBCs > 4,000/µL, absolute neutrophil count [ANC]>1,500/µL B. Hemoglobin >9.0 g/dL C. Platelets > 100,000/µL
- •Adequate kidney function (creatinine<1.5 mg/dL)
- •Adequate liver function (bilirubin<1.5 mg/dL [< 2.5 mg/dL for obstructive jaundice with adequately decompressed bile duct obstruction], transaminases levels<3 times the upper normal limit, and serum albumin of >2.5 mg/dL)
- •No serious medical or psychological condition that would preclude study treatment
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
排除标准
- •Other tumor type than adenocarcinoma
- •Evidence of GI bleeding or GI obstruction
- •Presence or history of CNS metastasis
- •Pregnancy or breastfeeding
- •Other serious illness or medical conditions
- •Axial skeletal radiotherapy within 6 months
- •Neuropathy grade 2 or worse
研究组 & 干预措施
SP treatment
S-1 plus cisplatin combination chemotherapy
干预措施: S-1 plus cisplatin (Drug)
GP treatment
Gemcitabine plus Cisplatin combination chemotherapy
干预措施: Gemcitabine plus Cisplatin (Drug)
结局指标
主要结局
Progression-free survival rate at 6 months
时间窗: 6 months
progression-free survival wad defined as the time from the date of enrollment to the date of the first occurrence of objective disease progression or death from any cause, which occur first.
次要结局
- Response rate(6 months)
- Toxicities(Up to 24 months)
- overall survival(up to 36 months)
研究者
JLee
Associate professor
Asan Medical Center