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临床试验/ACTRN12615000504516
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

发起方
Illawarra and Shoalhaven Local Health District

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