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临床试验/NCT02923622
NCT02923622Unknown不适用

Efficacy and Safety Evaluation of Traditional Chinese Medicine in the Treatment of Advanced Colorectal Cancer

Xiyuan Hospital of China Academy of Chinese Medical Sciences1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2016年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
384
试验地点
1
主要终点
Overall survival

研究概览

简要总结

Although patients of colorectal cancer use Traditional Chinese Medicine (TCM) herbal therapy extensively in China, no strong evidence exists to demonstrate the safety and survival outcomes of TCM herbal therapy combined with conventional western medicine for treatment of this disease. The purpose of this multi-center perspective cohort study is to evaluate the relationship between TCM herbal therapy and survival outcomes in patients with advanced colorectal cancer.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • histologically confirmed adenocarcinoma of the colon or rectum
  • TNM classification of stage IV disease according to American Joint Committee on Cancer
  • Between 18 and 80 years old
  • Progression or inability undergone conventional chemotherapy (Conventional chemotherapy regimen containing fluorouracil, oxaliplatin, irinotecan based chemotherapy, and all the above regimen should be used before)
  • Expected survival time is over 3 months
  • Signed informed consent

排除标准

  • serious non-malignant diseases such as heart, renal, and hepatic illnesses
  • the presence of other types of malignancies
  • The patients can not take medicine for intestinal obstruction

结局指标

主要结局

Overall survival

时间窗: 3 years

次要结局

  • Progress free survival(3 years)
  • Quality of life as assessed by FACT-C v4.0(3 years)
  • Tumor control rate(3 years)
  • TCM syndrome score(3 years)
  • Number of participants with treatment-related adverse events as assessed by Chinese version of CTCAE v4.0(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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