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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NA-TMT

    Radiation

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: NA-TMT1 intervention

Trial outcomes

Primary outcomes

1

DFS

Time frame
5 years
2

OS

Time frame
5 years
3

BI - EFS

Time frame
5 years

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: