Bladder cancer
Conditions
Interventions
Standard BCG Instillation Group:BCG Instillation
BCG Instillation and Placebo Group: BCG Instillation and Placebo
BCG Instillation and Antibiotics Group:BCG Instillation and Antibiotics
Sponsors
The Second Affiliated Hospital of Harbin Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, regardless of gender; 2.Subjects voluntarily sign the informed consent form and are able to complete the trial according to the protocol requirements; 3. Clinically diagnosed with non-muscle invasive bladder cancer (NMIBC), with diagnosis based on biopsy; 4. Subjects must have at least one measurable solid lesion in the body that can be accurately and continuously measured according to the modified RECIST criteria (version 1.1); 5. ECOG performance status of 0-2; 6. Laboratory indicators must meet the following requirements: (1) ALT and AST do not exceed three times the upper limit of normal, BUN and creatinine do not exceed 1.5 times the upper limit of normal; (2) Blood routine: 2*10^9/L = 80*10^9/L, Hb >= 80 g/L; (3) Other routine tests are within the normal range or considered acceptable by medical personnel.
Exclusion criteria
Exclusion criteria: 1. Recovery from major trauma (including surgery) within 4 weeks prior to receiving medical treatment; 2. Patients with severe systemic or localized infections or other serious comorbidities; 3. Patients with a known urine culture confirming fungal urinary tract infection within 2 weeks before randomization, with colony counts >=10^3 CFU/mL; 4. Patients with immune dysfunction or those who have recently used immunosuppressants or immunomodulators, including various vaccines; 5. Patients with autoimmune diseases, including rheumatoid arthritis; 6. Patients with inadequately controlled arrhythmias, including atrial fibrillation; 7. Heart failure (greater than New York Heart Association (NYHA) class II); 8. Patients with uncontrolled hypertension; 9. Subjects who are positive for syphilis, HBV, HCV, or HIV; 10. Male and female subjects of reproductive age who cannot use effective contraception; 11. Pregnant or breastfeeding women; 12. Patients with psychiatric disorders or relevant medical history; 13. Other subjects deemed unsuitable for enrollment by the medical technician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of immune cell subpopulations;Tumor recurrence rate;Progression-free survival; | — |
Countries
China
Contacts
Public ContactXuedong Li
The Second Affiliated Hospital of Harbin Medical University
Outcome results
None listed