Colorectal Cancer
Conditions
Interventions
None listed
Sponsors
Mie University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To participate in this study, all of the following criteria must be met. 1) Patients with unresectable advanced or recurrent colorectal cancer undergoing repeated administration of bevacizumab at 5-10 mg/kg (body weight) per dose, administered at least three times, in the Department of Gastrointestinal Surgery at our hospital between the date of approval and March 31, 2028. 2) Patients whose background information can be verified in medical records. 3) Patients whose informed consent to participate in the study can be confirmed based on their own volition.
Exclusion criteria
Exclusion criteria: Participants will be excluded from this study if they meet any of the following criteria: 1) Individuals for whom written consent to participate in the study could not be obtained 2) Individuals for whom a blood draw order was not placed within one month after consent was obtained 3) Patients under 18 years of age 4) Patients of foreign nationality
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare serum anti-drug antibody concentrations in Japanese patients administered bevacizumab with serum concentrations in clinical trials (Phase II or Phase III trials). Serum bevacizumab concentration per dose is evaluated against the compliance criteria, defined as the mean+/-2SD of the minimum plasma concentration (Cmin) during repeated dosing at 5 mg/kg, 7.5 mg/kg, and 10 mg/kg, as stated in the Avastin intravenous infusion interview form. | — |
Countries
Japan
Contacts
Public ContactTAKUYA IWAMOTO
Mie University Hospital Department of Pharmacy
Outcome results
None listed