NCT07279597

A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer

An Open, Single-arm Clinical Study on the Efficacy and Safety of Toripalimab Combined With RC48-ADC in Radiotherapy for HER-2 Positive Muscle-invasive Bladder Cancer (MIBC) Patients for Bladder Preservation Treatment After Chemotherapy Induction

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status. Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.

Detailed description

This is a prospective, open-label, single-center, single-arm clinical study. Plans to enroll 45 MIBC patients with clinical stage T2-T4aN0M0 and HER2-positive (IHC 1+/2+/3+) status. Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.

Conditions

• Muscle-invasive Bladder Urothelial Carcinoma

Interventions

Type	Name	Description
DRUG	RC48-ADC + Toripalimab	Treatment Flow: Post maximal Transurethral Resection of Bladder Tumor (TURBT); 2 cycles of Gemcitabine + Cisplatin chemotherapy; 4 cycles of RC48-ADC + Toripalimab targeted therapy; Radiotherapy (60-64 Gy) with concurrent Toripalimab treatment; Continue with 6 cycles of RC48-ADC + Toripalimab after radiotherapy completion; Patients achieving CR will receive maintenance therapy with Toripalimab for 1 year.

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-12-10
• Completion: 2028-08-01
• First posted: 2025-12-12
• Last updated: 2025-12-19