Urothelial carcinoma Urothelial carcinoma, Enfoltumab vedotin, Skin disorder
Conditions
Interventions
To realize whether prophylactic skin care intervention prior to treatment with enfolzumab vedotin can reduce the occurrence of skin disorders, patients will be applied with heparinoid from animal orga
Heparinoids, skin care
Sponsors
Nitta Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have agreed to be treated with enfoltumab vedotin for metastatic urothelial carcinoma 2) Patients who are at least 18 years of age at the time of consent 3) Patients with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2 4) Patients who are estimated by the attending physician to be expected to survive at least 3 months (5) Patients who have been fully informed about the study and who have written consent based on their full understanding of the study.
Exclusion criteria
Exclusion criteria: 1) Patients with hypersensitivity to heparinoid from animal organs 2) Patients already using hydrate foam animal organs 3) Patients who are applying steroid agent to the entire body 4) Patients with Grade 2 or higher skin disorder according to the CTCAE 5th edition at the time of enrollment. 5) Patients with any disease requiring oral or intravenous corticosteroid (prednisone equivalent >10 mg/day) or other immunosuppressive drugs within 14 days prior to enrollment. 6) Other patients deemed inappropriate as subjects by the Principal Investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Grade 2 or higher adverse skin events | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of skin adverse events for all CTCAE grades, median time to onset of skin disorders, response rate according to RECIST ver. 1.1, Relative Dose Intensity for padceb, dropout rate (number of patients who discontinued padceb treatment due to skin disorders/number of patients enrolled), identification of biomarkers for skin disorders | — |
Contacts
Public ContactTomokazu Kimura
University of Tsukuba Hospital
Outcome results
None listed