drugset / Trial / NCT04198051

The Clinical Study of Adjuvant Chemotherapy on Intestinal and Urethral Flora in Patients With Gastric and Colon Cancer

NCT04198051

NaSingle-groupOpen-labelOther

Summary

The human intestine is colonized with a complex microbial community and forms a super organism with the human body. Intestinal microorganisms include more than 1,000 kinds of bacterias, and their flora is very complex and functions are very diverse. The intestinal flora affects the body's nutrition, immunity and metabolism through interaction with the human body and the external environment, and is closely related to multiple systems. When the flora structure and function are changed, it will lead to the occurrence of various diseases or increase the risk of disease. In recent years, the role of intestinal microbes in tumorigenesis and development, as well as the role of diagnosis and treatment have been paid more and more attention. Abnormal intestinal flora can not only promote tumorigenesis, but also affect radiochemotherapy and immunotherapy effects. It is worth noting that the huge impact of the intestinal flora on immunotherapy suggests that immune checkpoint inhibitors can maximize the efficacy by protecting the balance and diversity of the intestinal microecology. Therefore, in this study, quantitative analysis of the diversity and abundance of intestinal, urinary tract flora, and urine components before and after adjuvant chemotherapy in patients with gastric and bowel cancer was performed. The link between treatment efficacy and prognosis.

Timeline

Start
2019-12-20
Primary completion
2020-12-20
Completion
2021-05-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 Oral
Subject Leucovorin Small molecule 400 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 85 mg/m2 Intravenous
Subject Oxaliplatin Small molecule 130 mg/m2 Intravenous
Subject S-1 Small molecule 80 mg/m2 Oral
Subject fluorouracil Small molecule 1200 mg/m2 Intravenous