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NCT Number: NCT07053722

Observational Clinical Study of Patients With Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy

The goal of this observational study is to evaluate the safety and efficacy of neoadjuvant therapy followed by bladder - preserving TMT in patients with MIBC. The main question it aims to answer is: Does this treatment model improve long - term outcomes, including survival, local control, distant metastasis, and bladder preservation rates? Participants who received neoadjuvant therapy and underwent TMT for bladder preservation will be observed.

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Key information

Conditions

Bladder (Urothelial, Transitional Cell) Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Histopathologically confirmed bladder cancer (T2-T4aN0-2M0, 8th edition AJCC staging).

Underwent bladder - sparing TMT following neoadjuvant therapy (ADC, immunotherapy, or chemotherapy).

Aged ≥18 years. Signed an informed consent form. Good general condition with ECOG performance status of 0-2. Adequate organ function for chemoradiotherapy: (1) Hematology: Absolute neutrophil count ≥1.5×10⁹/L, platelets ≥100×10⁹/L, hemoglobin ≥90 g/L. (2) Liver function: Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (≤5×ULN if hepatic metastasis is present). (3) 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.

Treatment and study plan

NA-TMT

Radiation

After neoadjuvant therapy, patients choose trimodality therapy (TMT) for bladder preservation over radical cystectomy.

Primary outcomes

  1. DFS

    Time frame: 5 years

  2. OS

    Time frame: 5 years

  3. BI - EFS

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Peking University First Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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