Muscle-invasive bladder cancer
Conditions
Interventions
None listed
Sponsors
Kitagawa Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients aged >= 18 years at the time of enrolment 2.Patients with MIBC (TNM classification; cT2-T4a N0-1 M0) 3.Patients scheduled to receive durvalumab and GC as NAC for MIBC, followed by RC 4.Patients who have provided written informed consent
Exclusion criteria
Exclusion criteria: 1.Patients who would be planned to be enrolled into any interventional clinical studies from MIBC diagnosis to the end of the durvalumab treatment 2.Patients diagnosed with transitional cell carcinoma or urothelial carcinoma developing from sites other than the bladder (i.e., ureter, urethra, or renal pelvis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFS from the start of durvalumab plus GC in patients with MIBC. The primary measure of interest is the EFS rate at 24 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.RC rate and summary of the reason for cancellation 2.Pathological T and N stage according to initial clinical T and N stage at the time of radical cystectomy 3.The concordance rate between cCR and pCR at the time of radical cystectomy 4.Surgical complication 5.immune-mediated adverse events (imAE) and severe adverse events (Severe AE) | — |
Contacts
Public ContactDaisuke kawai
AstraZeneca K.K.
Outcome results
None listed