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

NCT ID: NCT07053722

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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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

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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.

Detailed Description

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Conditions

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Bladder (Urothelial, Transitional Cell) Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NA-TMT

Patients with Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy

NA-TMT

Intervention Type RADIATION

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

Interventions

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NA-TMT

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

Intervention Type RADIATION

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shangbin QIN

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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NA-TMT-001

Identifier Type: -

Identifier Source: org_study_id

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