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A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

Muscle Invasive Bladder Carcinoma Clinical Trial

Official title:
An Open-label, Single-arm, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of RC48-ADC Combined With AK104 in Perioperative Treatment of Muscle-Invasive Bladder Cancer

Clinical Trial Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC combined with AK104 in perioperative treatment of muscle-invasive bladder cancer.

Clinical Trial Description

36 patients with Muscle-invasive Bladder Cancer（MIBC） scheduled for radical cystectomy will participate in this study. The patient had not previously received any antitumor system therapy for MIBC. HER2 expression in MIBC patients is defined as the expression of HER2 in tumor tissues detected by immunohistochemistry (IHC) as IHC 1+, 2+, or 3+. After enrollment, the subjects will receive 4 cycles neoadjuvant therapy and 14 cycles adjuvant therapy. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06074484
Study type Interventional
Source Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Contact xin wang, Doctor
Phone 87787170
Email WXCAMS@126.com
Status Recruiting
Phase Phase 2
Start date September 10, 2023
Completion date August 10, 2025
View Details
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