The effectiveness and safety of instillation of BCG and alternative BCG protocols for intermediate and high risk non-muscle invasive bladder cancer-Multi-institutional RCT

The effectiveness and safety of instillation of BCG and alternative BCG protocols for intermediate and high risk non-muscle invasive bladder cancer

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IIR-16008357

Enrollment

Unknown

Registered

2016-04-25

Start date

2015-05-01

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

bladder cancer

Interventions

A:After TURBT, one immediate instillation of epirubicin and 19 BCG

B:After TURBT, one immediate instillation of epirubicin and 15 BCG

C:After TURBT, one immediate instillation of epirubicin and 18 more epirubicin

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Willing to attend and sign the ICF; 2. All genders aged 18 to 75 years; 3. According to CUA Guideline for Bladder Cancer: 2014 Edition, diagnozed as non-muscle invasive bladder cancer (if receiving Sec-TUR, decision should be made after the pathological outcomes of Sec-TUR); 4. ECOG score 0-2.

Exclusion criteria

Exclusion criteria: 1. has one creteria below:immuno-defeciency,receiving immunosuppression therapy or radiotherapy,not tolerance of BCG or epirubicin,fever or acute infection (including active TB or TB in treatment), severe chronic cardiocerebrovascular diseases or chronic renal disease; 2. having other tumors simutaneously; 3. muscle invasive bladder cancer; 4. having chemotherepy, radiotherapy or immunotherapy in the past 4 weeks,except intermediate instillation of bladder; 5. Women who is in the situation of pegnancy, lactation,preparing pregnancy or men whose sexual partners are at pregnancy; 6. Known or suspecting perferation of bladder cancer; 7. gross hematuria at the time of decision of inclusion,for suspecting un-healing of operation lesion or injury of urologic tract mucosa; 8. having cystitis, or not tolerance of instillation; 9. attending other clinical trial in the past 3 months; 10. known addicted to opoid drug or alcohol; 11. not suitable to this trial evaluated by researchers.

Design outcomes

Primary

Measure	Time frame
5 year recurrence-free survival rate;	—

Secondary

Measure	Time frame
2, 3, 4 year recurrence-free survival rate;2, 3, 4, 5 year progression rate;vital sign;adverse events;	—

Countries

China

Contacts

Public ContactHuang Jian

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

urolhj@sina.com+86 13600054833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026