Observational Clinical Study on High - Risk NMIBC Patients Choosing Trimodality Bladder - Sparing Therapy

NCT07053748 | Not Yet Recruiting

• 1 other identifier: 2025-1081
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to assess the safety and efficacy of trimodality bladder - sparing therapy in high - risk NMIBC patients. The main questions it aims to answer are: Is trimodality therapy safe and effective in the short term for high - risk NMIBC patients? What is its long - term effectiveness in terms of EFS, OS, and BI - EFS? How does it affect patients' QOL? Participants will be high - risk NMIBC patients receiving trimodality therapy at Peking University First Hospital. They will be observed to evaluate the therapy's effectiveness and impact on QOL using relevant assessment criteria and QOL scores.

Conditions

High - Risk NMIBC

Keywords

Non-Muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (3)

• DFS

  5 years

• OS

  5 Years

• BI-DFS

  5 years

Study Arms (1)

TMT

High-risk NMIBC patients who have a strong desire to preserve their bladder actively choose to receive TMT bladder-preserving treatment instead of radical resection.

Radiation: Trimodality Bladder-preserving Therapy

Interventions

Trimodality Bladder-preserving Therapy RADIATION

High-risk NMIBC patients who have a strong desire to preserve their bladder actively choose to receive Trimodality Bladder-preserving Therapy instead of radical resection.

TMT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

High-risk patients with NMIBC who have a strong desire to preserve their bladder actively choose to receive TMT bladder treatment instead of radical resection.

You may qualify if:

• Histologically confirmed NMIBC (Ta Tis T1).
• ≥2 recurrences after transurethral resection, or lack of response/intolerance to intravesical therapy (e.g., BCG).
• Refusal of radical cystectomy and choice of TMT for bladder preservation. Aged ≥18 years. Signed informed consent. ECOG performance status of 0-2.
• Adequate organ function for chemoradiotherapy:
• Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L.
• Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present).
• Renal function: Creatinine clearance ≥30 mL/min (via Cockcroft-Gault formula).

You may not qualify if:

• Distant metastasis (M1). Other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ).
• Severe cardiovascular disease (uncontrolled heart failure, unstable angina, myocardial infarction, etc.).
• Severe hepatic/renal dysfunction intolerance to chemoradiotherapy. Mental illness/cognitive impairment unable to comply with the study. Allergy to chemoradiotherapy drugs. Pregnant or breastfeeding women. Previous pelvic radiotherapy.

Sponsors & Collaborators

• Peking University First Hospital: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-06