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

The efficacy and safety of intravesical immunotherapy with Pseudomonas aeruginosa injection (WTPA) to prevent post-operation recurrences in the patients with recurrent non-muscle-invasive bladder cancer: a prospective, randomized, parallel control study compared with intravesical Hydroxycamptotheci

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12002638

Enrollment

Unknown

Registered

2012-10-28

Start date

2012-11-01

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 group:Patients will receive ntravesical WTPA instillation (10 ml WTPA diluted to 50 ml with saline) started one week after TURBT, once a week for the first 2 months and once a month for the next

HCPT group:Patients will receive ntravesical HCPT instillation (20 mg HCPT in 30 ml saline) started one week after TURBT, once a week for the first 2 months and once a month for the next ten months

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18~75 years; 2. Histologically confirmed non-muscle invasive bladder urothelial carcinoma; 3. Complete transurethral resection of bladder tumor (TURBT); 4. Patients with biopsy-proven, stage Ta T1, grades 1~3; 5. Patients who had suffered from bladder urothelial carcinoma previously and received intravesical chemotherapeutics instillation (not HCPT) after surgery; 6. Patient is informed and has given written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with carcinoma in situ (Cis) at entry; 2. Patients with carcinoma stage T2 or higher; 3. Eastern Cooperative Oncology Group (ECOG) performance status 3~4; 4. Patients who received intravesical HCPT instillation prior to this recurrence; 5. Any concurrent malignancy or other history cancer; 6. Severe uncontrollable urinary tract infection; 7. Patients with congenital or acquired immune deficiency syndromes, or patients taking immunosuppressive drugs; 8. Pregnancy, lactation, or females in the reproductive ages who refuse to take adequate contraceptive measures; 9. History of multiple drug allergy; 10. Patients with known positive hepatitis A or hepatitis B; 11. Alcoholism, drug abuse; 12. Other exclusion criteria considered necessary by investigators.

Design outcomes

Primary

Measure	Time frame
Recurrence rate;	—

Secondary

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

Countries

China

Contacts

Public ContactZhoujun Shen

shenzj6@sina.com+86 21 64315370

Outcome results

None listed

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