NCT02425137已完成2 期
A Study of S-1 in Combination With Gemcitabine as First-Line Treatment in Patients With Advanced Biliary Tract Cancer
TTY Biopharm4 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2015年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Disease control rate (DCR)
研究概览
简要总结
Primary Objective:
To evaluate disease control rate (DCR) of S-1 in combination with gemcitabine in patients with advanced biliary tract cancer
Secondary Objectives:
- To evaluate overall response rate (ORR)
- To evaluate progression-free survival (PFS)
- To evaluate overall survival (OS)
- To assess the safety profile
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.histologically confirmed biliary tract carcinoma (including intrahepatic bile duct, extrahepatic bile duct, gallbladder, and ampulla of vater);
- •2.metastatic or unresectable disease;
- •3.no history of chemotherapy or radiotherapy for biliary tract cancer;
- •4.presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be ≥15 mm in the short axis;
- •5.adequate hematopoietic function which is defined as below:
- •hemoglobin level ≥ 9 g/dL;
- •absolute neutrophil count (ANC) ≥ 1,500/mm3;
- •platelet count ≥ 100,000/mm3;
- •6.adequate hepatic function which is defined as below:
- •total bilirubin ≤ 1.5 times upper limit of normal (ULN) and < 2 mg/dL, or total bilirubin < 3 mg/dL if biliary drainage was performed;
- •Alanine aminotransferase (ALT) ≤ 3 x ULN or ALT ≤ 5 x ULN in the presence of liver metastasis;
- •7.adequate renal function: creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockroft-Gault formula);
- •8.age of 20 years or above;
- •9.ECOG performance status 0-1;
- •10.life expectancy of at least 12 weeks;
- •11.ability to take oral medication;
- •12.ability to understand and willingness to sign a written informed consent document.
排除标准
- •1.other malignancy within the past 5 years except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ;
- •2.history or known presence of brain metastasis;
- •3.presence of grade 2 or above ascites or pleural effusion;
- •4.presence of grade 2 or above diarrhea;
- •5.presence of mental disease or psychotic manifestation;
- •6.active or uncontrolled infection;
- •7.significant medical conditions that is contraindicated to study medication or render patient at high risk from treatment complications based on investigator's discretion;
- •8.pregnant women or nursing mothers, or positive pregnancy test for women of childbearing potential. Patients with childbearing potential shall have effective contraception for both the patient and his or her partner during the study.
研究组 & 干预措施
S-1/Gemcitabine
Experimental
single-arm
干预措施: S-1/Gemcitabine (Drug)
结局指标
主要结局
Disease control rate (DCR)
时间窗: 2 years
Disease control is defined as having confirmed complete or partial response or stable disease
次要结局
- Objective response rate (ORR)(2 years)
- safety profile (percentage of patients with at least one occurrence of preferred term will be included,according to the most severe NCI-CTCAE v4.03 grade)(2 years)
- progression-free survival (PFS)(2 years)
- overall survival (OS)(2 years)
研究者
研究点 (4)
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