Non-muscle invasive bladder cancer
Conditions
Interventions
Group B:Intravesical instillation of Gemcitabine.
Group C:Intravesical instillation of Compound Kushen Injection and Gemcitabine.
Group A:Intravesical instillation of Compound Kushen Injection.
Sponsors
First hospital of Shanxi Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Male and female aged 18 to 75 years; 2. Histologically clear non-muscular invasive bladder urothelial carcinoma ,according to the 2014 of the CUA guidelines, assessment is clearly defined as moderate or high risk; 3. Complete transurethral resection of bladder tumor (TURBT); 4. ECOG score 0-2; 5. Willing to attend and sign the ICF; 6. Patients have good compliance and willing to follow up on the program.
Exclusion criteria
Exclusion criteria: 1. Muscle invasive bladder cancer(patients with carcinoma stage T2 or higher); 2. Other histologic types of bladder cancer, combined with other histologic types of bladder cancer (such as adenocarcinoma, squamous cell carcinoma etc); 3. Imaging revealed metastasis of other sites; 4. Combined with other carcinoma; 5. Having cystitis, or not tolerance of instillation; 6. Pregnancy, lactation, or females in the reproductive ages who refuse to take adequate contraceptive measures; 7. Urethral stricture, cannot insert urethral canal; 8. Bladder effective volume <=50ml; 9. Patients with congenital or acquired immune deficiency syndromes, or patients taking immunosuppressive drugs; 10. Not suitable to attend this trial evaluated by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| recurrence rate;progression rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse reactions;disease-specific survival rate;living quality;overall survival rate; | — |
Countries
China
Contacts
Public ContactWeibing Shuang
First hospital of Shanxi Medical University
Outcome results
None listed