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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Qiang Cao, PhD
• Email: qiang_cao@126.com
• Phone: +8615151211913

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.