Bladder-sparing treatment for large non-muscle-invasive bladder cancer

A Bladder-Sparing Treatment Strategies of Large-Volume Non-Muscle-Invasive Bladder Cancer

This study is testing new bladder-sparing treatments for people with large non-muscle-invasive bladder cancer to see if they can improve outcomes while keeping the bladder intact.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: The First Affiliated Hospital with Nanjing Medical University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Pembrolizumab, doxorubicin
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06735287 on ClinicalTrials.gov

What this trial studies

This clinical trial focuses on patients diagnosed with large non-muscle-invasive bladder cancer (NMIBC) and aims to evaluate bladder-sparing treatment strategies. The study utilizes multiparametric MRI (MpMRI) and the VI-RADS scoring system to accurately stage tumors and identify candidates for neoadjuvant chemotherapy and immunotherapy. Eligible participants must have tumors of a certain size and a specific VI-RADS score, ensuring they can tolerate the proposed treatments. The trial seeks to improve treatment outcomes while preserving bladder function.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 80 with large non-muscle-invasive bladder cancer who meet specific health criteria.

Not a fit: Patients with muscle-invasive bladder cancer or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option for patients with large NMIBC, potentially improving quality of life.

How similar studies have performed: Other studies utilizing MpMRI and the VI-RADS scoring system have shown promising results in identifying NMIBC, suggesting this approach may be effective.

Eligibility criteria

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 therapy after TURBT. Male or female, aged ≥18 and \<80 years. Voluntary participation with written informed consent, and ability to understand and comply with study requirements, including regular follow-up.

Exclusion Criteria:

* Preoperative imaging assessment with VI-RADS ≥3. Postoperative pathology showing non-urothelial carcinoma (e.g., adenocarcinoma, squamous cell carcinoma, small cell carcinoma, or mixed tumors), or urothelial carcinoma ≥T2.

Presence of lymph node and/or distant metastases. Allergy or hypersensitivity to treatment drugs, or patients with autoimmune diseases.

Any condition deemed by the investigator to potentially harm the participant or prevent them from meeting or fulfilling study requirements.

Where this trial is running

Nanjing, Jiangsu

• The first affiliated hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Qiang Cao, PhD

Conditions Bladder Cancer; NMIBC