Clinical trial · Observational
Observational Clinical Study of Patients With Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy
NCT07053722CI-TRIAL-00091840not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder (Urothelial, Transitional Cell) Cancer | Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NA-TMT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- NA-TMT
- description
- Patients with Muscle - Invasive Bladder Cancer Undergoing Bladder Preservation Therapy After Neoadjuvant Therapy
- interventionNames
- Radiation: NA-TMT
Primary outcomes (3)
- measure
- DFS
- timeFrame
- 5 years
- measure
- OS
- timeFrame
- 5 years
- measure
- BI - EFS
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.