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
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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NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2025-06-30
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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NA-TMT
Patients with Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy
NA-TMT
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Responsible Party
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Shangbin QIN
Doctor
Other Identifiers
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NA-TMT-001
Identifier Type: -
Identifier Source: org_study_id
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