RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients

This study is an open, single-arm, single-center exploratory clinical study to explore the efficacy and safety of Disitamab Vedotin (RC-48) in combination with radiotherapy for the treatment of patients with HER2-expressing high-risk or very high-risk non-muscle invasive bladder cancer (NMIBC) without visible foci of disease after transurethral resection of bladder tumor (TURBT). The study plans to enroll 30 patients with high or very high risk HER2-expression NMIBC without visible lesions after TURBT. The study includes a screening period, a treatment period, and a survival follow-up period. This is a single-center study conducted at the Peking University First Hospital, and the PI is Prof. CuiJian Zhang.

NCT Number	NCT07100184
Lead Sponsor	Peking University First Hospital Collaborators: RemeGen Co., Ltd.
Conditions	HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT
Enrollment	30 participants
Start Date	2025-09-01
Primary Completion	2028-05-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-08-03