Bladder cancer
Conditions
Interventions
Experimental group:Intravesical BCG therapy
Control group:Intravesical BCG therapy
Sponsors
Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with clinically diagnosed bladder tumor were diagnosed as non muscle invasive bladder cancer by biopsy or TURBT histology, and were assessed as patients with medium and high risk of recurrence or progression according to the 2018 edition of Chinese bladder cancer diagnosis and treatment standard. 2. Patients with tumor number less than or equal to 5; 3. Subjects aged 18 years <= 80 years, male or female. 4. The patients who voluntarily signed the informed consent can cooperate to complete the whole trial.
Exclusion criteria
Exclusion criteria: 1. Patients with preoperative imaging findings of lymph node invasion (N1 stage) or distant metastasis (M1 stage). 2. Patients with immune deficiency or damage (such as AIDS patients), who are using immunosuppressive drugs or radiotherapy, may cause systemic BCG disease response. Patients with fever and acute infectious diseases, including active tuberculosis, or receiving anti tuberculosis treatment; 3. Patients with severe infectious diseases such as bacteremia and toxemia. 4. Patients with severe coagulation dysfunction, or severe heart, brain, lung, liver, kidney and other diseases, can not tolerate surgery. 5. Patients with other malignant tumors. 6. Pregnant or lactating women. 7. Patients with severe urethral stricture, cystitis, or severe bladder irritation and other complications that can not tolerate cystoscopic surgery or bladder perfusion. 8. Patients with drug prohibition, including systemic anti-tumor drugs. 9. Patients participating in other clinical trials at the same time. 10. Researchers believe that there may be other situations that increase the risk of subjects or interfere with the implementation of clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence free suvival;progression free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Local recurrence rate; | — |
Countries
China
Contacts
Public ContactHaowen Jiang
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed