Prolonged Intravesical Use after TURBT in Moderate or High risk Non–Muscle-Invasive Bladder Cancer:Multicenter, randomized controlled, open, prospective clinical study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17011476

Enrollment

Unknown

Registered

2017-05-24

Start date

2017-06-01

Completion date

Unknown

Last updated

2017-06-05

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

Conditions

Bladder cancer

Interventions

Routine Intravesical instillation:Intravesical use begins at 1-2 weeks after TURBT, once a week for 8 weeks and later once per month,for 10 months

Prolonged Intravesical instillation:Intravesical use begins at 1-2 weeks after TURBT, once a week for 8 weeks and later once per month,Lasted for 3 years after TURBT

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged > = 18 years; 2. Histologically clear non muscular invasive bladder urothelial carcinoma; 3. According to the 2014 of the CUA guidelines, assessment is clearly defined as Moderate or High risk; 4. ECOG=5 years; 6. Informed consent can be signed by itself; 7. Patients have good compliance and are willing to follow up on the program.Since the date of screening, contraception must be carried out throughout the study period until 3 months after the lasted Intravesical Use.

Exclusion criteria

Exclusion criteria: 1. Invasive bladder urothelial carcinoma; 2. According to the 2014 of the CUA guidelines, assessment is clearly defined as low risk; 3. Other histologic types of bladder cancer, combined with other histologic types of bladder cancer (such as adenocarcinoma, squamous cell carcinoma etc.; 4. Imaging revealed metastasis of other sites; 5. combined with other carcinoma; 6. Allergic reactions of epirubicin; 7. under Intravesical instillation of other drugs; 8. Urethral stricture, cannot insert urethral canal; 9. Prior intravesical instillation of epirubicin; 10. Other clinical studies are being planned or planned; 11. Female pregnancy; 12. Bladder effective volume <=50ml.

Design outcomes

Primary

Measure	Time frame
3 year recurrence rate;	—

Secondary

Measure	Time frame
3 year progression rate;5 year recurrence rate;3 year progression rate;Adverse Effects Rate;	—

Countries

CHINA

Contacts

Public ContactZhigang.JI

Chinese Academy of Medical Sciences.PEKING Union Medical Collage Hospital

JZG1129@medmail.com.cn+86 10-69152520

Outcome results

None listed

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