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NOT YET RECRUITING
NCT05912205
PHASE2

Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation

Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

View on ClinicalTrials.gov

Summary

This is a prospective, open, single center clinical study of vidicizumab combined with local radiotherapy as bladder conserving therapy in patients with muscle invasive bladder urothelium cancer with HER-2 expression (IHC 2+or 3+). A total of 30 subjects were included in the study

Official title: An Open, Single Arm, Phase II Clinical Study on the Efficacy and Safety of Bladder Sparing Therapy With Vidixizumab Combined With Local Radiotherapy in Patients With HER-2 Expressing Myometrial Invasive Urothelium Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2023-07-01

Completion Date

2026-07-01

Last Updated

2023-06-22

Healthy Volunteers

No

Interventions

DRUG

Disitamab Vedotin

Four cycles of neoadjuvant therapy with Vidiximab (2.0mg/kg) were administered first, followed by bladder sparing therapy using maximized TURBT combined with radiotherapy and chemotherapy. The patient will receive vidiximab combined with local radiotherapy after maximizing TURBT surgery. The subjects received treatment with Vidixitol every two weeks for six consecutive treatment cycles, and simultaneously received 1 month of radiation therapy (SBRT, total dose of bladder irradiation field greater than 50 Gy)

RADIATION

radiotherapy

radiotherapy