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

Launched by PEKING UNIVERSITY FIRST HOSPITAL · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment option called trimodality bladder-sparing therapy for people with a type of bladder cancer known as high-risk non-muscle invasive bladder cancer (NMIBC). This treatment aims to control the cancer while keeping the bladder intact, avoiding the need for bladder removal surgery. The study will observe how safe and effective this approach is both in the short term and over a longer period. It will also check how this treatment affects patients' quality of life, including their overall health and daily well-being.

People who may be eligible to join this study are adults with high-risk NMIBC who have had at least two recurrences of their cancer after standard surgery, or who did not respond well or could not tolerate usual bladder treatments like BCG therapy. Participants must have decided against bladder removal surgery and chosen this bladder-sparing treatment instead. They should be generally healthy enough to handle chemotherapy and radiation, and able to give informed consent. If accepted, participants will be closely monitored at Peking University First Hospital to see how well the treatment works and how it impacts their quality of life. This study is not yet recruiting patients but aims to provide important information for people looking for bladder-preserving options.

Gender

ALL

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.