Randomized Phase III Trial Comparing Gemcitabine/Cisplatin/S-1 With Gemcitabine/Cisplatin for Unresectable Biliary Tract Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 246
- 试验地点
- 1
- 主要终点
- Overall survival rate
研究概览
简要总结
To validate the superiority of Gemcitabine/Cisplatin/S-1 over Gemcitabine/Cisplatin for unresectable biliary tract cancer.
详细描述
Gemcitabine/cisplatin combination therapy (GC) has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). Investigators have evaluated the efficacy and safety of gemcitabine/cisplatin/S-1 combination therapy (GCS) for patients with advanced BTC and observed the promising efficacy. In this randomized phase Ⅲ study, investigators aimed to compare GCS with GC in patients with advanced BTC.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cytologically or histologically proved biliary tract cancer
- •age >=20 years
- •Performance Status (PS) 0-2
- •No prior history of chemotherapy or radiotherapy.
- •Adequate bone marrow function (neutrophil count >=1,500/mm3, and platelet count >=100,000/mm3), liver function (total bilirubin >=3 mg/dL and AST/ALT >=150 IU/L), and renal function (creatinine clearance >=45 mL/min)
- •Adequate oral intake
- •Provided written informed consent -
排除标准
- •Patients with interstitial pneumonia or pulmonary fibrosis
- •Patients with uncontrollable diabetes mellitus, liver disease, angina pectoris or a new onset of myocardial infarction within 3 months
- •Patients with severe active infection
- •Patients with moderate or marked pleural effusion or ascites necessitating drainage
- •Patients with a history of severe drug allergy
- •Patients with other serious comorbid disease
- •Patients who are pregnant or lactating, or have an intention to get pregnant
- •Patients with mental disease
- •Patients who are judged inappropriate for the entry into the study by the principle doctor
研究组 & 干预措施
Gemcitabine/Cisplatin group
Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
干预措施: Gemcitabine/Cisplatin /S-1 (Drug)
Gemcitabine/Cisplatin /S-1 group
S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
干预措施: Gemcitabine/Cisplatin (Drug)
结局指标
主要结局
Overall survival rate
时间窗: Probability of 1-year survival (%)
The primary endpoint is designated to evaluate overall survival rate at 12-month.
次要结局
- Number of Participants with Adverse Events as a Measure of Safety(24 months)
- Progression free survival(Every 3 months, up to 24 months)
- Response rate(Every 3 months, up to 24 months)