Disitamab Vedotin Combined With Radiotherapy for Bladder Preservation

Urothelial Carcinoma Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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

Clinical Trial Description

A total of 30 subjects were included in the study. Each subject underwent diagnostic bladder resection (TURBT) and imaging diagnosis, and biological samples such as blood, urine, and biopsy tissue were collected before treatment. After myometrial invasive bladder cancer with HER2 expression (IHC 2+or 3+) judged by pathological tissue, four cycles of neoadjuvant therapy with vedixizumab (2.0mg/kg) was first performed, and then bladder conserving therapy was performed by maximizing TURBT combined with radiotherapy and chemotherapy. The patient will receive vidiximab combined with local radiotherapy after maximizing TURBT surgery. The subjects received a treatment cycle of six consecutive treatment cycles of vidixitol every two weeks, and simultaneously received one month of radiation therapy (SBRT, with a total dose of over 50 Gy in the bladder irradiation field). After completing the above treatment, tumor evaluation will be conducted through imaging and exfoliative cytology. After the completion of radiotherapy, the first tumor efficacy evaluation will be conducted. After the end of radiotherapy, tumor efficacy evaluation will be conducted every 6 weeks. Patients who are not tolerant to radiotherapy (evaluated by the researchers) will directly discontinue the medication. ;

Related Conditions & MeSH terms

• Carcinoma
• Urothelial Carcinoma

• NCT number: NCT05912205
• Study type: Interventional
• Source: Wuhan Union Hospital, China
• Contact: zhang xiaoping, doctor
• Phone: 027-85726375
• Email: xzhang@hust.edu.cn
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 1, 2023
• Completion date: July 1, 2026