Muscle-invasive urothelial carcinoma of the bladder (MIBC)
Conditions
Interventions
Intervention group:tislelizumab+RC48
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the clinical observation, have the ability to independently choose treatment and sign the written informed consent to participate in the clinical observation; 2. No gender limit, aged at least 18 years on the date of signing the informed consent; 3. Urothelial carcinoma confirmed by cystoscope histology, with evidence of myographic infiltration (the assessment of myographic infiltration can be based on pathological diagnosis or imaging diagnosis); Note: If patients with specific components are considered, such as vascular lymphatic infiltration, sarcomatoid differentiation, squamous differentiation, adenoid differentiation, micropapillary, nestlike, plasmacytoid differentiation, and neuroendocrine differentiation, the patient's pathological data should be evaluated by an experienced pathologist specializing in urinary oncology. 4. Urothelial carcinoma with infiltrating bladder muscle layer (cT2-4aN0-2M0) was initially diagnosed as HER2-positive (immunohistochemical indication of 1+, 2+, and 3+); 5. Patients who completed baseline chest and abdominal CT, pelvic MRI, PET/CT, etc.; 6. Adequate heart, bone marrow, liver, kidney and other organ functions: (1) Neutrophils >= 1.5x10^9 /L; (2) Hemoglobin >= 9 g/dL (no infusion of concentrated red blood cells within 2 weeks); (3) Platelet >= 100x10^9 /L; (4) ALT = 50ml/min; (7) Normal or abnormal coagulation function (PT, APTT, TT, Fbg) had no clinical significance; 7. Life expectancy over 12 months; 8. ECOG physical strength score 0 or 1; 9. Willing and able to follow research and follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. Autoimmune central diseases that have not reached a stable condition; 2. Active or progressive infection requiring systemic treatment, such as active tuberculosis, active hepatitis, etc.; 3. Systemic diseases that have not been stably controlled according to researchers, including diabetes, hypertension, cirrhosis, and severe lung diseases; 4. Pregnant or lactating patients; 5. Any other disease, metabolic abnormality, abnormal physical examination, or abnormal laboratory test that, in the investigator's judgment, is reasonably suspected to have a disease or condition that would be inappropriate for the use of the study drug, would affect the interpretation of the study results, or would put the patient at high risk; 6. It is estimated that the patient's compliance to participate in this clinical study is insufficient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete response rate;Pathologic complete response; | — |
Countries
China
Contacts
Public ContactShen Yali
Outcome results
None listed