NCT07100184

RC48 in Combination With Radiotherapy for HER2-Expressing NMIBC Patients

Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for Patients With HER2-Expressing High-Risk or Very High-Risk Non-Muscle Invasive Bladder Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• HER2-expressing High-risk or Very High-risk NMIBC Without Visible Foci of Disease After TURBT

Interventions

Type	Name	Description
DRUG	Disitamab Vedotin combined with Radiotherapy	Disitamab Vedotin (RC-48) injection 2mg/kg, Q2w for 4 circles before radiotherapy and 2mg/kg, Q3w for 8 circles after radiotherapy; Radiotherapy (Whole bladder dose: 25 Gy in 5 doses, QD)

Timeline

• Start date: 2025-09-01
• Primary completion: 2028-05-31
• Completion: 2028-12-31
• First posted: 2025-08-03
• Last updated: 2025-08-03