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

NCT ID: NCT07053748

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-30
• Study Completion Date: 2027-06-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Trimodality Bladder-preserving Therapy

Intervention Type: 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.

Interventions

Trimodality Bladder-preserving Therapy

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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shangbin QIN

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2025-1081

Identifier Type: -

Identifier Source: org_study_id