Spots Global Cancer Trial Database for A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer

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Trial Identification

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

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

Study ID: NCT06074484

Conditions

Muscle Invasive Bladder Carcinoma

Interventions

RC48-ADC

AK104

Study Description

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

Detailed 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.