bladder cancer
Conditions
Interventions
test group:Neoadjuvant treatment with RC48-ADC monotherapy was initiated within =48 hours of inclusion in the study and 3 cycles of neoadjuvant treatment prior to RC+PLND (2.0 mg/kg RC48-ADC on Day 1/
Sponsors
Affiliated Hospital of Guangdong Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age = 18 years; 2) Case-confirmed diagnosis of MIBC; 3) MIBC with previous platinum-containing chemotherapy or unsuitable for platinum-based chemotherapy; 4) HER2 overexpression (IHC 2+/3+); 5) MIBC with clinical stage T3-T4aN0M0; 6) UC of the upper urinary tract or urethra not allowed to be included; 7) Urothelial carcinoma subtype accounting for >50%; 8) ECOG physical status score (PS) of 0-2; 9) Patients who are clinically fit for RC+PLND; 10) Organ function levels must meet the following requirements (no transfusion or haematopoietic growth factor therapy within 2 weeks prior to blood screening): ? ANC = 1.5 x 109/L; ?PLT = 100 x 109/L; ?Hb=90 g/L; ?TBIL = 1.5 x ULN (except for subjects with Gilbert's syndrome); ?ALT and AST = 2.5 x ULN; ?Cr = 1.5 x ULN; ?LVEF=50%. 11) Voluntarily participate in this clinical trial, understand the study procedures and have signed informed consent.
Exclusion criteria
Exclusion criteria: Subjects will not be allowed to enter this study if they meet any of the following criteria: (1) Previous other malignancies within 3 years prior to inclusion in the study (with the exception of carcinoma in situ that has gone into complete remission and malignancies that are slow to progress as determined by the investigator); 2) Presence of serious uncontrolled concomitant disease such as persistent active infection, autoimmune disease, immunodeficiency, history of organ transplantation, etc. that may affect protocol compliance or interpretation of results; 3) Treatment with other clinical investigational drugs and major surgery within 4 weeks prior to inclusion in this study; 4) Presence of concomitant diseases (e.g., poorly controlled hypertension, severe diabetes mellitus, neurological or psychiatric disorders, etc.) or any other condition that, in the investigator's judgement, is a serious risk to patient safety, may confound the results of the study, or affects the subject's ability to complete this study; 5) Presence of active cardiac disease within 6 months prior to inclusion in the study, including: severe/unstable angina pectoris, myocardial infarction, symptomatic congestive heart failure (cardiac class III or IV), and ventricular arrhythmias requiring pharmacological treatment; 6) Previous antineoplastic therapy with ADC drugs; 7) known history of hypersensitivity to RC48-ADC drug components;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathology downgrade rate,; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathologic complete response, PCR;Event-free survival, EFS;Overall survival, OS;Disease free survival, DFS; | — |
Countries
China
Contacts
Public ContactLiu Hongwei
Affiliated Hospital of Guangdong Medical University
Outcome results
None listed