drugset / Trial / NCT05773391

Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)

NCT05773391 ↗

Unknown 100 enrolled Sun Yat-sen University
Non-randomizedParallel-groupOpen-labelPrevention

Summary

Small-molecule tyrosine kinase inhibitors (TKI) that target HER2 are routinely used to treat patients with HER2 (+) breast cancer. The main adverse reactions included diarrhea, nausea, and rash, among which diarrhea had the highest incidence. It can reduce the quality of life and medication compliance of patients, and further affect the efficacy of TKI anti-tumor therapy. Therefore, the investigators conducted this study to establish a risk assessment model before TKI treatment, in order to screen out the high-risk population and influencing factors of TKI-associated diarrhea, and planned to carry out corresponding animal experiments to verify the relationship between various mechanisms and the main mechanism in TKI-associated diarrhea and to explore the corresponding treatment methods.

Timeline

Start
2023-04-12
Primary completion
2023-08
Completion
2024-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Jin Bifid Unknown 2 g Oral
Subject Yihuo Unknown 0.2 g Oral

Indications