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Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer

RECRUITINGN/ASponsored by Changhai Hospital
Actively Recruiting
PhaseN/A
SponsorChanghai Hospital
Started2024-06-01
Est. completion2026-06-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06889623

Summary

Residual tumors after transurethral resection of bladder tumors (TURBT) range from 17-70%, and floating tumor cells from traditional segmental resection may lead to recurrence if they re-implant in the bladder wall. Immediate systemic chemotherapy post-surgery aims to eliminate microlesions promptly and minimize recurrence risk, yet its safety and efficacy require further exploration. This prospective, single-arm study delves into evaluating the efficacy and safety of immediate postoperative systemic chemotherapy in patients with suspected high-risk non-muscle-invasive bladder cancer.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients with a history and cystoscopy results indicating high-risk NMIBC:

  * High-grade T1
  * Any recurrent high-grade Ta
  * High-grade Ta \& Tumor diameter greater than 3 cm or multifocal
  * Any CIS
  * Any BCG failure in patients with high-grade disease
  * Any variant histology
  * Any LVI
  * Any high-grade prostatic urethral involvement
* Patients in generally good condition with a follow-up period of 2 years

Exclusion Criteria:

* Bladder cancer other than UC
* MIBC or benign diseases
* Incomplete tumor resection
* Active infection
* Concurrent upper urinary tract or prostatic urethral UC
* Previous systemic chemotherapy, immunotherapy, or radiotherapy
* Leukopenia/thrombocytopenia
* Serum creatinine greater than twice the normal level
* Uncontrollable urinary tract infection

Conditions2

CancerNMIBC

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