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Effect of Intravesical BCG Instillation Time on Immunotherapy Efficacy in Non-Muscle-Invasive Bladder Cancer: A Randomized Controlled Trial

Effect of Intravesical BCG Instillation Time on Immunotherapy Efficacy in Non-Muscle-Invasive Bladder Cancer: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094253
Enrollment
Unknown
Registered
2024-12-19
Start date
2024-12-31
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Bladder Cancer

Interventions

BCG Morning Group:Morning intravesical BCG instillation
BCG Afternoon Group:Afternoon intravesical BCG instillation

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Individuals aged 18 years or older with full civil capacity, who fully understood the study and signed the informed consent; (2) Patients with urothelial carcinoma (without squamous cell or multiple cell type differentiation) initially confirmed by histology or cytology; (3) Patients who required BCG intravesical (induction + maintenance) instillation after transurethral resection of bladder tumor (TURBT); (4) ECOG performance status score of 0-1; (5) TNM stage: Ta/T1N0M0.

Exclusion criteria

Exclusion criteria: (1) Patients with other malignant tumors; (2) Failure of early BCG infusion; (3) Patients with serious underlying diseases or complications; (4) Patients who have received special immunotherapy and have been assessed to be immunocompromised or immunodeficient; (5) Patients who are pregnant or breastfeeding; (6) Patients with serious abnormalities in clinical laboratory tests (such as liver and kidney function, blood gas analysis); (7) Patients with serious mental health problems.

Design outcomes

Primary

MeasureTime frame
Tumor recurrence rate;Relapse free survival, RFS;Progression free survival, PFS;Overall survival, OS;

Secondary

MeasureTime frame
Laboratory examinations;

Countries

China

Contacts

Public ContactHan Ping

Department of Urology/Institute of Urology, West China Hospital, Sichuan University, Chengdu, Sichuan, China.

hanping@scu.edu.cn+86 180 8060 1955

Outcome results

None listed

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