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

Launched by THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVERSITY · Dec 11, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for patients with large non-muscle-invasive bladder cancer (NMIBC), specifically tumors that are 5 cm or larger. The goal is to find a way to treat these tumors while preserving the bladder and maintaining the patient's quality of life, instead of relying solely on major surgery, like radical cystectomy, which can have significant risks and impact on daily living. The study will explore the use of advanced imaging techniques and therapies, such as chemotherapy and immunotherapy, to help manage these large tumors effectively.

To participate in the trial, candidates must be adults aged 18 to 80 with a confirmed diagnosis of large NMIBC, have a specific pre-surgery imaging score, and be able to tolerate certain treatments. Participants will receive careful monitoring and treatment options aimed at reducing tumor recurrence while keeping their bladder intact. It's important to note that this study is still recruiting participants, and those interested should discuss it with their healthcare provider to see if they meet the eligibility criteria.

Gender

ALL

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.