Muscle invasive bladder cancer
Conditions
Interventions
Experimental group:Iparomlimab and Tuvonralimab Injection+Chemotherapy (albumin-bound paclitaxel + carboplatin)
Sponsors
Tianjin Cancer Hospital Airport Hospita
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Understand and voluntarily sign the informed consent form for this study. 2.Age >=18 years, regardless of gender. 3.Patients with muscle-invasive bladder urothelial carcinoma (MIBC) confirmed by histopathology, without concurrent upper urinary tract urothelial carcinoma. 4.Clinical staging (cT2-T4a, N0-1, M0) and no distant metastasis confirmed by imaging evaluation. 5.ECOG performance status score of 0-1. 6.After imaging evaluation, the subject is deemed eligible and planned to undergo radical cystectomy. The subject has not received any prior systemic antitumor therapy or radiotherapy for MIBC. 7.Expected survival >=3 months. 8.Adequate cardiac, bone marrow, hepatic, and renal function. 9.Eligible patients of childbearing potential must agree to use reliable contraceptive methods with their partners during the trial and for at least 180 days after the last dose of the study drug.
Exclusion criteria
Exclusion criteria: 1.Inability to comply with the study protocol or study procedures. 2.Prior antitumor therapy, including radiotherapy, targeted therapy, immunotherapy, and investigational antitumor drugs, before the initiation of the study treatment. 3.Major surgery within 4 weeks before the initiation of the study treatment. 4.Allergy or hypersensitivity to the study drug or its excipients, or a history of allergic constitution. 5.Active or progressive infection requiring systemic treatment, such as active tuberculosis. 6.Heart failure classified as Grade 3 or higher by the New York Heart Association (NYHA). 7.Uncontrolled systemic diseases, as determined by the investigator, including diabetes, hypertension, liver cirrhosis, interstitial pneumonia, obstructive pulmonary disease, etc. 8.Positive HIV test; positive hepatitis B surface antigen (HBsAg) with HBV-DNA above the upper limit of normal; active hepatitis C virus (HCV) infection. 9.Active autoimmune diseases requiring systemic treatment (e.g., immunomodulators, corticosteroids, or immunosuppressants) before the initiation of the study treatment. Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) are allowed. 10.Systemic glucocorticoid therapy or other immunosuppressants within 14 days before the first dose, or immunostimulants (including but not limited to interferon or interleukin-2) within 4 weeks before the first dose. 11.History of other malignancies within 5 years before enrollment, except for basal cell or squamous cell skin cancer or cervical carcinoma in situ after curative resection. 12.Active autoimmune disease or a history of autoimmune disease within 4 weeks before enrollment. 13.Patients deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical complete response rate/pathological complete response rate, cCR/pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate,ORR;Pathological response rate;1-year event-free survival(EFS) rate;Overall survival,OS;Safety; | — |
Countries
China
Contacts
Public ContactYang Qing
Tianjin Cancer Hospital Airport Hospita
Outcome results
None listed