Bladder cancer
Conditions
Interventions
Experimental group -single arm:Observational study without intervention
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1: Male or female, aged = 18 years on day of signing informed consent 2: Subjects have voluntarily agreed to participate by giving written informed consent 3: Patients with confirmed muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy (RC) 4: Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5: Eligible patients must have had radical surgery within 120 days 6: Eligible patients must have been disease-free as determined by means of a complete physical examination and imaging within 4 weeks
Exclusion criteria
Exclusion criteria: 1: Patients with partial cystectomy 2: Patients with recurrence or metastasis after radical cystectomy 3: Patients to be treated with immune checkpoint inhibitors who: a.Patients with active autoimmune disease or a history of autoimmune disease with potential relapse;b.Any medical conditions requiring systemic corticosteroid therapy (prednisone at a dose higher than 10 mg/d or equivalent) or other immunosuppressive agents within 14 days before treatment; c.Known history of HIV infection; d.Untreated chronic hepatitis B or HBV DNA > 500 IU/mL(2500 cps/mL) in chronic HBV carriers or patients with active hepatitis;e.PD-(L)1 therapy except for tislelizumab, toripalimab, sintilizumab 4: A history of malignancy within the past 3 years, in addition to a cured or remitted malignancy 5: Allergy to treatment drugs or other conditions that cannot be taken/treated 6: Other investigators assessed eligibility for inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) rate of 2-year; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS, disease-free survival;Overall survival, OS;DSS, disease-specific survival;DMFS, Distant metastasis–free survival;NUTRFS, non–urothelial tract recurrence–free survival; | — |
Countries
China
Contacts
Public ContactBin Fu
The First Affiliated Hospital of Nanchang University
Outcome results
None listed