NIPH Clinical Trials Search

JRCT ID: jRCTs031220257

Registered date:08/08/2022

The study of Preventive Approach for Skin Trouble caused by Enfortumab vedotin treatment for urothelial cancer

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedUrothelial carcinoma
Date of first enrollment11/04/2023
Target sample size30
Countries of recruitment
Study typeInterventional
Intervention(s)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 organs 2 weeks prior to administration of enfolzumab vedotin.


Primary OutcomeIncidence of Grade 2 or higher adverse skin events
Secondary OutcomeIncidence 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

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
Include criteria1) 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.
Exclude criteria1) 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.

Related Information


Public contact
Name Tomokazu Kimura
Address 2-1-1 Amakubo,Tsukuba Ibaraki Japan 305-8576
Telephone +81-29-853-3223
Affiliation University of Tsukuba Hospital
Scientific contact
Name Satoshi Nitta
Address 2-1-1 Amakubo,Tsukuba Ibaraki Japan 305-8576
Telephone +81-29-853-3223
Affiliation University of Tsukuba Hospital