Bladder cancer
Conditions
Interventions
experimental group:TURBT, cryoablation and PLND
control group:radical cystectomy, PLND and urinary diversion
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: For Experimental Arm I 1. High grade T1 or localized muscle-invasive(T2-T4a)bladder cancer confirmed by pathological evidence; 2. The number of tumor sites is no more than 5; 3. Male or female, aged 18 to 85 years; 4. Intention for bladder-sparing or unfit for radical cystectomy; 5. Patients will sign written informed consent and comply with follow-up, treatment and examination during the study. For Experimental Arm II 1. High grade T1 or localized muscle-invasive(T2-T4a)bladder cancer confirmed by pathological evidence; 2. The number of tumors sites is no more than 5; 3. Male or female, aged 18 to 85 years; 4. Patients will sign written informed consent and comply with follow-up, treatment and examination during the study.
Exclusion criteria
Exclusion criteria: 1. Patients with known allergic reaction to adjuvant immunotherapy; 2. Patients with severe infectious diseases such as bacteremia and toxemia; 3. Patients who have severe coagulopathy; 4. Patients are suffering from severe heart, brain, lung, liver, kidney diseases, that cannot tolerate the surgery; 5. Patients are suffering from other malignant tumors; 6. Pregnant or lactating women; 7. Patients with contraindication for cystoscopy, eg. severe urethral stricture; 8. Patients with contraindication of either systemic chemotherapy or immunotherapy; 9. Patients are enrolled in any other concurrent trial; 10. Patients who have any other conditions that are not appropriate for the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Local recurrence rate;quality of life; | — |
Countries
China
Contacts
Public ContactHaowen Jiang
Department of Urology, Huashan Hospital affiliated to Fudan University
Outcome results
None listed