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Clinical Trial Summary

A multicenter, open, single arm, phase II clinical trial was designed for myometrial invasive bladder cancer to evaluate the efficacy and safety of RC48-ADC combined with gemcitabine in preoperative neoadjuvant treatment of MIBC, and provide high-level clinical evidence for gemcitabine combined with ADC in the treatment of MIBC


Clinical Trial Description

Patients with myometrial invasive bladder cancer expressing HER2 and not suitable for cisplatin chemotherapy were treated with vedixizumab (RC48) 2.0mg/kg, once every two weeks, intravenous drip (60-90min); Gemcitabine is 1000mg/m2, once every two weeks. After completing 3 cycles of neoadjuvant combined therapy, imaging evaluation was performed. If the tumor is T0, radical surgery for bladder cancer was performed; Otherwise, perform radical surgery for bladder cancer (total cystectomy+standard/extended lymph node dissection) after completing 1-3 cycles of treatment. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05723991
Study type Interventional
Source Tongji Hospital
Contact Zhiquan hu, doctor
Phone 13971656164
Email huzhiquan2000@163.com
Status Recruiting
Phase Phase 4
Start date September 28, 2022
Completion date September 28, 2025

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