Study of Disitamab Vedotin Combined With Gemcitabine in Neoadjuvant Treatment of Urothelial Carcinoma

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

Inclusion Criteria:Subjects voluntarily joined the study, signed the informed consent form, and were able to follow the study and follow-up proceduresAge 18-75Suitable and planned for radical cystectomy (including lymph node dissection)Clinical stage T2-T4aN0M0 (CT/MR/PET-CT evaluation)Pathologically, it is urothelial carcinoma, and the patient has HER2 expression and refuses neoadjuvant chemotherapy or physical condition/renal function [glomerular filtration rate (GFR) 30-60mL/min], which is not suitable for neoadjuvant chemotherapy (pathology allows urothelial carcinoma to merge with other variant subtypes, with urothelial carcinoma as the main type)ECOG score 0 or 1There is residual tumor after TURBT (cystoscopy or imaging evidence)The blood test of subjects should meet the following requirementsExclusion Criteria:Receive live attenuated vaccine within 4 weeks before enrollment or during the study period.Have received systemic chemotherapy and targeted therapy of anti-PD-1, PD-L1 and HER2 in the past 6 monthsKnown allergy to gemcitabine/RC48 and its componentsActive, known or suspected autoimmune diseases.A history of primary immunodeficiency is known.