Cetuximab Plus Gemcitabine-Oxaliplatin (GEMOX) in Patients With Unresectable Advanced or Metastatic Biliary Tract Cancer: a Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- best overall response (according to RECIST 1.0)
研究概览
简要总结
The aim of this prospective single-centre phase II study is to investigate the therapeutic efficacy and safety of cetuximab in combination with Gemcitabine and Oxaliplatin (GEMOX) in the palliative first line treatment of biliary tract cancer (BTC) patients.
详细描述
Primary Objective(s) The primary objective of the study is to evaluate the best overall response of cetuximab in combination with gemcitabine and oxaliplatin (GEMOX) as first line treatment in patients with advanced or metastatic biliary tract cancer.
Secondary Objectives
The secondary objectives of this study are as follows:
- toxicity
- secondary resection rate
- progression-free survival (PFS)
- overall survival (OS)
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
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
- •histologically or cytologically proven unresectable advanced or metastatic biliary tract cancer (including intrahepatic and extrahepatic CC and gallbladder cancer)
- •age ≥ 18 years
- •ECOG performance status ≤ 2
- •bidimensionally measurable disease per RECIST criteria
- •no prior chemotherapy or targeted therapy for advanced disease
- •adequate bone marrow reserve (neutrophil count > 1500 /µL, platelet count > 100,000 /µL)
- •adequate renal function (serum creatinine ≤ 1.5 x the upper limit of normal)
- •adequate hepatic function (serum bilirubin <2.5 x the upper limit of normal (ULN) and serum transaminase level of ≤ 5 x ULN)
- •written informed consent
排除标准
- •prior palliative treatment
- •resectable disease
- •brain metastases
- •serious or uncontrolled concurrent medical illness
- •pregnancy or nursing
- •history of other malignancies with the exception of excised cervical or basal skin/squamous cell carcinoma
- •peripheral neuropathy (grade > 1)
结局指标
主要结局
best overall response (according to RECIST 1.0)
时间窗: after an average of 2 months
overall response rate (ORR) will be measured after each 4 cycles (average 2 months) of Cetuximab +GEMOX and the overall best response recorded
次要结局
- Safety of the treatment combination(approximately 6 months)