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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer, Capecitabine

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group cap<br>Patients receiving capecitabine chemotherapy after operation | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | Adverse Events That Are Related to Treatment | during chemotherapy | 
| Disease-free survival |  | Three year disease-free survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three year disease free survival rate |  | Three year disease free survival rate | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarks, colorectal cancer, capecitabine, gene polymorphism