A Clinical multi-center, randomized, open-label, blank control trial of Cystistat in combination with THP by co-perfusion to reduce complications induced by THP-chemotherapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-10000788

Enrollment

Unknown

Registered

2010-02-08

Start date

2009-12-01

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

complications induced by THP instillation/non-muscle invasive tumor

Interventions

Group B:30mg THP diluted with 50ml water for injection, after routine disinfection, place catheters in the bladder and empty the bladder, then give THP perfusion, by injecting a small amount of air to

Group A:30mg THP diluted with 50ml water for injection. After routine disinfection, place catheters in the bladder and empty the bladder then give THP perfusion, by injecting a small amount of air to

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Newly diagnosed patients or patients with relapse bladder tumor more than one year; 2. Treated with THP instillation after TUR-BT surgery; 3. 18 to 75 years old; 4. Pathologically diagnosed as primary non-invasive bladder cancer, TNM staging of T1, Ta or Tis.

Exclusion criteria

Exclusion criteria: 1. Patients with relapse bladder tumor; 2. Allergic to THP, Doxorubicin and HA; 3. With tumors or cancers in other system or organs, and treated with enough anthracycline chemotherapy and radiation; 4. Uncontrolled urinary tract infection; 5. Severe systemic disease or chronic wasting disease (diabetes, cardiovascular diseases, as well as liver and kidney dysfunction etc.); 6. Bladder wall perforation after TUR-BT; 7. Pathologically diagnosed as invasive bladder transitional cell carcinoma or other types of tumors or cancers; 8. Pregnancy or breast-feeding; 9. Participated in any other investigational drug study; 10. Other conditions not appropriate to be selected according to investigators' consideration, such as mental disorders, etc.

Design outcomes

Primary

Measure	Time frame
VAS score for bladder pain;	—

Secondary

Measure	Time frame
Urine routine examination;Bladder tumor recurrence rate in first year and second year;The case proportion in each group on completion of THP perfusion weekly;WHO toxicity assessment on hematuria and bladder irritation;	—

Countries

China

Contacts

Public ContactYanqun Na, Zhangqun Ye, Ningchen Li

ningchenli@126.com+86 13910708351

Outcome results

None listed

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