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Exploratory study on the difference of efficacy of neoadjuvant therapy patients with bladder cancer.

Exploratory study on the difference of efficacy of neoadjuvant therapy patients with bladder cancer.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500107063
Enrollment
Unknown
Registered
2025-08-04
Start date
2025-08-06
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

bladder cancer

Interventions

Case series:No

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 78 Years

Inclusion criteria

Inclusion criteria: Patients must meet all of the following inclusion criteria to be included in this study: 1. Age range: 18-78 years old; 2. The patient must have histologically confirmed muscle infiltrating bladder urothelial carcinoma, which has been clinically determined as cT2-T4a, N0, M0 based on imaging evaluation; 3. The physical condition (PS) score of the Eastern Cooperative Oncology Group (ECOG) is 0 or 1; 4. Life expectancy >= 10 years; 5. Patients who choose radical cystectomy as the main treatment for muscle invasive bladder urothelial carcinoma; 6. Normal liver function: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 35g, no ascites or hepatic encephalopathy; 7. Normal coagulation function: INR = 50%; QTc= 60 mL/min; 10. The ability of the subjects to understand and be willing to sign informed consent forms; Be able to comply with research visit schedules and other protocol requirements.

Exclusion criteria

Exclusion criteria: Patients with any of the following conditions are not eligible for inclusion in this study: 1. There are other malignant tumors present; 2. Previous experiences include immunotherapy, targeted therapy, platinum chemotherapy (such as cisplatin, carboplatin, or others), as well as other chemotherapy and radiotherapy; 3. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases, active or symptomatic viral hepatitis or chronic liver disease; 4. Clinically significant heart diseases, such as NYHA III-IV heart failure, myocardial infarction, or arterial thrombosis events in the past 6 months, severe or unstable angina, or recent ventricular arrhythmias; 5. Pituitary dysfunction and adrenal cortex dysfunction; 6. Uncontrollable severe hypertension, hypokalemia, water and sodium retention; 7. Pre existing duodenal stents and/or any gastrointestinal diseases or defects that researchers believe may interfere with drug absorption; 8. Allergic to neoadjuvant drugs or other contraindications to use; The researcher considers it inappropriate to participate in this clinical trial for any reason.

Design outcomes

Primary

MeasureTime frame
pathologic complete response;

Secondary

MeasureTime frame
The impact of neoadjuvant therapy on surgery;Safety within 90 days after neoadjuvant therapy surgery;Safety during neoadjuvant therapy;

Countries

China

Contacts

Public ContactHongzhao Li

Department of Urology, Chinese PLA General Hospital

urolancet37@163.com+86 158 0109 1018

Outcome results

None listed

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