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A randomized, controlled, open-label, prospective clinical study for prolonged perfusion in patients with moderate to high-risk non-muscle invasive bladder cancer

A randomized, controlled, open-label, prospective clinical study for prolonged perfusion in patients with moderate to high-risk non-muscle invasive bladder cancer

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026392
Enrollment
Unknown
Registered
2019-10-07
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

bladder cancer

Interventions

Control:Gemcitabine 1g diluted with 50ml normal saline
Eperimence:Gemcitabine 1g diluted with 50ml normal saline

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years; 2) Histologically defined non-muscle invasive bladder urothelial carcinoma; 3) According to the 2014 edition of the guidelines for the diagnosis and treatment of urological diseases in China, the risk assessment is clearly classified as intermediate or high risk; 4) ECOG score = 5 years; 6) You can sign your informed consent form by yourself; 7) The patient has good compliance and is willing to follow up according to the program; 8) Contraceptive measures were taken from the date of screening throughout the study period until 3 months after the last perfusion treatment.

Exclusion criteria

Exclusion criteria: 1) Combined with other histological types of bladder cancer (eg, adenocarcinoma, squamous cell carcinoma, small cells, etc.); 2) Imaging examination revealed tumor metastasis in other parts of the bladder; 3) Combine other malignant tumors; 4) had an allergic reaction to gemcitabine; 5) are participating in or planning to participate in other clinical studies; 6) The urethra is narrow and cannot be inserted into the urethra; 7) Effective bladder capacity <= 50ml; 8) Previous history of intravesical infusion of gemcitabine; 9) Female pregnancy.

Design outcomes

Primary

MeasureTime frame
Recurrence-free survival rate 1 year after surgery;

Countries

China

Contacts

Public ContactHu Hailong

The Second Hospital of Tianjin Medical University

guobao888888@126.com+86 13116050182

Outcome results

None listed

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