bladder cancer
Conditions
Interventions
experimental group:immune checkpoint inhibitor
experimental group:chemotherapy (gemcitabine and cisplatin)
Sponsors
Department of Urology,Huashan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Admission criteria for test group: 1) The patient was clinically diagnosed as bladder tumor and was classified as high-risk non muscle invasive bladder cancer or T2-T3 muscle invasive bladder cancer by biopsy or TURBT. High risk nonmuscular bladder cancer is defined as any of the following: a. T1 tumor; b. High grade urothelial carcinoma; c. At the same time: multiple, recurrent and bladder cancer with diameter>3cm 2) Number of tumors = 5; 3) 18 = age = 85, male or female; 4) Willing to protect bladder; 5) Willingly sign the informed consent form, and can cooperate to complete the whole experiment. 2. Admission criteria for control group: 1) The patient was clinically diagnosed as bladder tumor, and was classified as high-risk non muscle invasive bladder cancer or T2-T3 muscle invasive bladder cancer by biopsy or TURBT; High risk nonmuscular bladder cancer is defined as any of the following: a. T1 tumor; b. High grade urothelial carcinoma; c. At the same time: multiple, recurrent and bladder cancer with diameter>3cm 2) Number of tumors = 5; 3) 18 = age = 85, male or female; 4) Willingly sign the informed consent form, and can cooperate to complete the whole experiment.
Exclusion criteria
Exclusion criteria: 1. The preoperative imaging showed that the organs around the bladder (such as ureter, prostate, rectum, etc.), pelvic cavity or abdominal wall were involved, or lymph node metastasis (N1) and distant metastasis (M1) had occurred. 2. Known hypersensitivity to chemotherapy drugs and/or immunotherapy drugs; 3. Accompanied with serious infectious diseases such as bacteremia and toxemia; 4. Those with severe coagulation dysfunction; 5. Suffering from serious heart, brain, lung, liver, kidney and other diseases, unable to tolerate surgery; 6. Other malignant tumors; 7. Pregnant or lactating women; 8. Complications such as severe urethral stricture that cannot tolerate cystoscopy; 9. Those who are combined with prohibited drugs, including systemic anti-tumor drugs and immunosuppressants; 10. Participants in other clinical trials at the same time; 11. Other circumstances that the investigator considers inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival;progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intravesical recurrence rate;intravesical progression rate;adverse event rate;quality of life; | — |
Countries
China
Contacts
Public ContactHaowen Jiang
Huashan Hospital Fudan University
Outcome results
None listed