NCT05123625 Prognostic Effect of Whether Doing PLND During RC for High-risk NMIBC

Eligibility & Interventions

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This trial targets 200 participants in total. It began in 2021-07-01 with a primary completion date of 2027-06-30.

Brief Summary

There is no consensus on the need for lymph node dissection in radical cystectomy (RC) for high-risk non-muscular invasive bladder cancer (NMIBC). Investigators divided participants at high risk of NMIBC without enlarged lymph nodes as indicated by pelvic MRI into two groups 1:1. One group of participants underwent RC combined with lymph node dissection and the other group of participants only underwent RC. The incidence of complications and PFS/OS at 1, 3, and 5 years were compared.

Eligibility Criteria

Inclusion Criteria: 1. Patients who did not undergo diagnostic transurethral resection of bladder tumor (TURBT): biopsy suggestive of G3/high grade or with CIS or cystoscopic findings of multiple, tumor diameter greater than 3 cm; and VI-RADS score of 1 or 2; and no enlarged lymph nodes detected by MRI. 2. Patients undergoing diagnostic TURBT: pathologically confirmed high-risk NMIBC, a) stage T1; b) G3 or high-grade; c) CIS; d) multiple, recurrent TaG1G2/low-grade bladder cancer patients with \>3 cm in diameter. And no enlarged lymph nodes detected on MRI. 3. Benefit from radical cystectomy as assessed by the investigator. 4. Meeting the indications for the procedure: a) absolute neutrophil count ≥ 1.5 \*109/L; b) platelets ≥ 100 \*109/L; c) hemoglobin ≥ 90 g/L; d) international normalized ratio or activated partial thromboplastin time ≤ 1.5 upper limit of normal (ULN); e) calculated creatinine clearance ≥ 1 ml/s f) serum total bilirubin ≤ 1.5 \* ULN; g) AST, ALT and alkaline phosphatase ≤ 2.5 \* ULN; h) cardiopulmonary function suggestive of tolerance to major abdominal surgery. 5. No previous history of tumor, lymph node dissection, or immune system-related disease. 6. Age 18 to 75 years. 7. No neoadjuvant therapy. 8. ECOG physical status 0 or 1. 9. Voluntary participation in this trial, ability to provide written informed consent, and understanding and agreement to comply with the requirements of this study and the evaluation schedule. Exclusion Criteria: 1. Patients with bladder cancer ≥ T2N0M0 confirmed by pathology or assessed by imaging, or with pelvic lymph node enlargement indicated by MRI; 2. The investigator assessed patients who could not tolerate radical cystectomy; 3. Previous systemic chemotherapy or immunotherapy; 4. The presence of active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of large amounts of hormones and other immunosuppressants; 5. Had undergone major surgery or major trauma within 28 days before enrollment; 6. Received live vaccine within 28 days before enrollment; 7. Severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy within 14 days prior to enrollment; 8. Received any Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before enrollment; 9. Participating in other clinical studies.

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