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

• Conditions: Colorectal Cancer; Capecitabine
• Interventions: Other: No intervention

• Registration Number: NCT03030508
• Lead Sponsor: Shanghai Changzheng Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Status Verified: 2017-01
• Study First Submitted: 2017-01-13
• Study First Submitted QC: 2017-01-22
• Last Update Submitted: 2017-01-22
• Study First Posted: 2017-01-25
• Last Update Posted: 2017-01-25
• Primary Completion: 2019-01
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group cap	No intervention	Patients receiving capecitabine chemotherapy after operation

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Three year disease free survival rate	Three year disease free survival rate

Trial Locations

Locations (1)

Department of medicine of Shanghai Changzheng Hospital; 🇨🇳 Shanghai, Shanghai, China