NCT03258099

Association of Genetic Polymorphisms With Capecitabine-based Chemotherapy Toxicities in Chinese Solid Tumor Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Cui Yimin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors. However, variability in toxicity and response remains a major problem for patients receiving capecitabine. It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Toxicities of capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to the levels of evidence of those studies are low and lack of sufficient research data of Chinese, it has the important significance in studying individual differences of capecitabine in toxicities, through the pharmacogenomics research. The aim of this study is to evaluating the association genetic polymorphisms with capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG) correlation of capecitabine and provide scientific basis for precise medication guide for people to use capecitabine.

Conditions

• Solid Tumor
• Capecitabine
• Drug-Related Side Effects and Adverse Reactions
• Pharmacogenetics
• Pharmacokinetics

Interventions

Type	Name	Description
GENETIC	detection of genotype	detection of genotype by next generation sequencing

Timeline

• Start date: 2017-12-28
• Primary completion: 2019-10-01
• Completion: 2019-12-01
• First posted: 2017-08-23
• Last updated: 2019-08-28

Locations

7 sites across 1 country: China