A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2027

Conditions
Bladder (Urothelial, Transitional Cell) Cancer
Interventions
DRUG

Disitamab Vedotin

Each patient will receive Disitamab Vedotin injection \[2.0 mg/kg, Q2W, iv\], with an expected total of 12 courses of treatment. The specific number of treatment cycles is determined by researchers based on the patient's response to the treatment, tolerance to the treatment plan, and comprehensive assessment of the condition. Patients with safety intolerance caused by any drug treatment should reduce or discontinue the medication according to the dosage adjustment plan specified in the plan. The medication is diluted with physiological saline and administered intravenously for one hour.

DRUG

PD-1 inhibitor

Each patient will receive Triprolizumab injection \[3mg/kg, Q2W, iv\], with an expected total of 12 courses of treatment. The specific number of treatment cycles is determined by researchers based on the patient's response to the treatment, tolerance to the treatment plan, and comprehensive assessment of the condition. Patients with safety intolerance caused by any drug treatment should reduce or discontinue the medication according to the dosage adjustment plan specified in the plan. The medication is diluted with physiological saline and administered intravenously for one hour.

RADIATION

radiotherapy

"1. Whole bladder treatment, recommended scope of application: T2 Suggestion: The total bladder radiotherapy dose is 2Gy/day, five times a week, up to a dose of 50Gy/25 times, to cover at least 95% of the planned target volume (PTV full bladder).~ The radiation dose for shrinking the field to bladder tumors is 2Gy/day, five times a week, with a total dose of 14Gy/7 times, to cover at least 95% of the planned target dose (PTV bladder tumors).~2. Whole pelvic radiotherapy (whole bladder+selective pelvic lymph node radiotherapy), applicable range: T3-T4a Suggestion: Whole pelvic radiotherapy at 2Gy/day, five times a week, up to a dose of 46Gy/23 times, to cover at least 95% of the planned target dose.~Reduce the dosage to 2Gy/day for the entire bladder and up to 4Gy/twice. Bladder tumor (PTV bladder tumor) 2Gy/day, five times a week, with a total dose of 14Gy/7 times, to cover at least 95% of the planned target volume.~The above radiotherapy plan is a suggestion, and the specific plan will"

Trial Locations (1)

200127

Renji Hospital, Shanghai Jiaotong University School of Medecine, Shanghai

All Listed Sponsors
lead

RenJi Hospital

OTHER