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

Naval Military Medical University (Second Military Medical University)

Status: Unknown

Conditions: Capecitabine; Colorectal Cancer

Treatments: Other: No intervention

Study type: Observational

Funder types: Other

Identifiers

NCT03030508

WChen

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

300 participants in 1 patient group

Group cap

Description:

Patients receiving capecitabine chemotherapy after operation

Treatment:

Other: No intervention