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临床试验/NCT03030508
NCT03030508Unknown不适用

Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients

Shanghai Changzheng Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

研究概览

简要总结

At present, chemotherapy is widely used in the adjuvant treatment of colorectal cancer patients after surgery. Capecitabine is one of the main chemotherapeutic drugs. But the effect is not good enough, the adverse reaction is serious, and the individual differences were significant. The present study shows that these problems are related to the differences in the exposure of capecitabine and its metabolites in different patients. The genetic biomarkers for capecitabine include DRD, MTHFR and TYMS. Mutations in these genes directly affect the expression of metabolic enzymes involved in capecitabine and control the concentration of capecitabine and its metabolites. However, these markers have been obtained through clinical trials in the United States, and their role in predicting the effectiveness or safety of capecitabine and its metabolites has not been validated in Chinese cancer patients.The study was based on a case study of patients with colorectal cancer in China, and capecitabine as the primary postoperative chemotherapy regimen to verify whether the available biomarkers can be used to predict the effectiveness and safety of capecitabine. To clarify the effect of capecitabine on endogenous metabolites, and to study the mechanism of its effect, so as to discover new biomarkers.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • more than 18 years old;
  • patients with colon cancer diagnosed by biopsy (regardless of cancer stage);
  • received postoperative containing capecitabine chemotherapy;
  • volunteer to participate in the experiment

排除标准

  • pregnant and lactating women;
  • patients with hypersensitivity to fluorouracil or severe metabolic failure;
  • patients with severe infection;
  • patients with other cancers other than colorectal cancer within the first five years of colorectal cancer surgery;

结局指标

主要结局

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

时间窗: during chemotherapy

Adverse Events That Are Related to Treatment

Disease-free survival

时间窗: Three year disease-free survival

次要结局

  • Three year disease free survival rate(Three year disease free survival rate)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wansheng Chen

Professor, Director of Department of Pharmacy

Shanghai Changzheng Hospital

研究点 (1)

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