ACTRN12615000504516已完成2 期
Patients with advanced biliary cancer to be treated with second line combination chemotherapy of NAB Paclitaxel and capecitabine in a single arm pilot study to assess feasibility
Illawarra and Shoalhaven Local Health District0 个研究点目标入组 10 人开始时间: 2015年5月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •1. Histologically proven unresectable biliary tract cancer
- •2. Prior chemotherapy with gemcitabine/platinum. Patient must have either progressed on chemotherapy or be intolerant to either drug.
- •3. >18 years
- •4. Measurable disease according to RECIST
- •5. Good performance status
- •6. Adequate bone marrow function
- •7. Adequate hepatic function
- •8. Adequate renal function
- •9 Planned to start treatment within 30 days of registration
- •10. Willing and able to comply with study requirements
- •11. Signed, written informed consent
排除标准
- •1. Previous treatment with a taxane or fluoropyrimidines
- •2. Prior hypersensitivity to paclitaxel or albumin
- •3. Significant underlying medical conditions that may be aggravated by study treatment
- •4. Significant peripheral neuropathy
- •5. Life expectancy of less than 3 months
- •6. Untreated brain metastases or leptomeningeal disease
- •7. History of another malignancy within 2 years prior to registration.
- •8. Concurrent illness including severe infection
- •9. Presence of any psychological, familial, sociological or geographical condition that may hamper compliance
- •10. Pregnancy, lactation, or inadequate contraception
研究者
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