Intravesical immunotherapy with WTPA to prevent post-operation recurrences in patients with non-muscle invasive bladder cancer

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-14005615

Enrollment

Unknown

Registered

2014-11-19

Start date

2014-10-01

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

Non-muscle invasive bladder cancer

Interventions

WTPA:Patients will receive ntravesical WTPA instillation (10 ml WTPA diluted to 40 to 50 ml with saline) started one week after TURBT, once a week for six times, and once a week at the third month for

Pirarubicin:Patients will receive ntravesical Pirarubicin instillation (30 mg Pirarubicin in 40~50 ml saline) started one week after TURBT, once a week for 2 months and once a month for the next ten m

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years; 2. Histologically confirmed non-muscle invasive bladder urothelial carcinoma; 3. Complete transurethral resection of bladder tumor (TURBT); 4. All non-muscle invasive bladder cancer except for the single Ta, G1 stage and tumor less than 3cm (also satisfies the condition of the low risk of non muscle invasive bladder cancer); 5. Patient is informed and has given written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with carcinoma stage T2 or higher; 2. Eastern Cooperative Oncology Group (ECOG) performance status 3~4; 3. Any concurrent malignancy or other history cancer; 4. Severe uncontrollable urinary tract infection; 5. Patients with congenital or acquired immune deficiency syndromes, or patients taking immunosuppressive drugs; 6. Pregnancy, lactation, or females in the reproductive ages who refuse to take adequate contraceptive measures; 7. History of multiple drug allergy; 8. Patients with known positive hepatitis A or hepatitis B; 9. Alcoholism, drug abuse; Other exclusion criteria considered necessary by investigators.

Design outcomes

Primary

Measure	Time frame
Recurrence rate;	—

Secondary

Measure	Time frame
Urinary tract infection incidence;Adverse reactions;Relapse-free survival;Progression-free survival;Distant metastasis-free survival;Overall survival;	—

Countries

China

Contacts

Public ContactDongWen Wang

urology2007@126.com+86 13753126918

Outcome results

None listed

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