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NOT YET RECRUITING
NCT07865611
PHASE2

Response-Guided Bladder Preservation With Trastuzumab Rezetecan, Adebrelimab, and Concurrent Bladder Radiotherapy in HER2-Expressing Muscle-Invasive Bladder Cancer

Sponsor: Tongji Hospital

View on ClinicalTrials.gov

Summary

This prospective, multicenter, open-label phase II study will evaluate a response-guided bladder-preservation strategy in patients with HER2-expressing muscle-invasive bladder cancer. Participants will receive maximal transurethral resection of the bladder tumor, trastuzumab rezetecan plus adebrelimab, and concurrent bladder radiotherapy. Treatment response will be assessed by cystoscopic biopsy or diagnostic transurethral resection at 8 weeks (±2 weeks) after radiotherapy. Participants with a pathological stage of T1 or lower may continue bladder-preserving management, whereas radical cystectomy will be recommended for participants with disease above T1. The primary outcome is the major pathological response rate.

Official title: A Prospective, Multicenter, Open-Label Phase II Study of Response-Guided Bladder Preservation With Trastuzumab Rezetecan Plus Adebrelimab and Concurrent Bladder Radiotherapy in Patients With HER2-Expressing Muscle-Invasive Bladder Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

70

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-10-08

Healthy Volunteers

No

Interventions

DRUG

Trastuzumab Rezetecan

Trastuzumab rezetecan will be administered intravenously at a dose of 4.8 mg/kg every 3 weeks for 4 cycles.

DRUG

Adebrelimab

Adebrelimab will be administered intravenously at a dose of 1200 mg every 3 weeks for 4 cycles.

RADIATION

Concurrent Bladder Radiotherapy

Bladder radiotherapy will be delivered to a total dose of 60-64 Gy in 30-32 fractions, at 2.0 Gy per fraction, once daily, 5 fractions per week, over approximately 6 weeks. Radiotherapy will be initiated concurrently with systemic therapy.

PROCEDURE

Transurethral Resection of Bladder Tumor

Participants will undergo maximal transurethral resection of the bladder tumor before combined treatment. Cystoscopic biopsy or diagnostic TURBT will be performed at 8 weeks (±2 weeks) after radiotherapy to assess pathological response.

Locations (1)

Tongji Hospital

Wuhan, Hubei, China