A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer
Bladder cancer is a common malignancy in the urinary system, ranking 11th in cancer incidence in China (3.48/100,000), with male incidence ranking 8th (5.70/100,000). It is classified as non-muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) based on muscle involvement. About 75% of patient
| Condition(s) | Bladder Cancer, NMIBC |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | Bladder cancer is a common malignancy in the urinary system, ranking 11th in cancer incidence in China (3.48/100,000), with male incidence ranking 8th (5.70/100,000). It is classified as non-muscle-invasive bladder cancer (NMIBC) or muscle-invasive bladder cancer (MIBC) based on muscle involvement. About 75% of patients are initially diagnosed with NMIBC, with Ta, T1, and Tis stages comprising 70%, 20%, and 10%, respectively. With the advancement of magnetic resonance imaging (MRI), its role in bladder cancer diagnosis and staging has expanded. Multiparametric MRI (MpMRI) enhances staging accuracy with better anatomical visualization. In 2018, Valeria et al. introduced the VI-RADS scoring system, which uses MpMRI to predict tumor stage. Retrospective studies by Wang et al. found that all t |
| Who can participate | Inclusion Criteria: \- Diagnosis of large non-muscle-invasive bladder cancer: Tumor size ≥5 cm, ≤3 tumors, pre-TURBT VI-RADS score \<3, or biopsy confirms non-muscle-invasive urothelial carcinoma. Ability to tolerate neoadjuvant chemotherapy and immunotherapy: Sufficient heart, bone marrow, liver, and kidney function (according to clinical trial center normal values), no severe hematologic abnormalities or organ dysfunction (heart function 0-2, WBC ≥3.5×10⁹/L, neutrophil count ≥1.5×10⁹/L, PLT ≥75.0×10⁹/L, HGb ≥80 g/L; liver function: total bilirubin ≤1.5×ULN, AST and ALT ≤2.5×ULN; kidney function: creatinine ≤1.5×ULN, or GFR ≥60 ml/min if creatinine \>1.5×ULN). ECOG performance status: 0 or 1. No history of other malignancies. Able to receive regular mitomycin C bladder instillation therap |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Locations | Nanjing, Jiangsu, China |
| Start date | 2024-12-01 |
| NCT ID | NCT06735287 |
| Official listing | https://clinicaltrials.gov/study/NCT06735287 |