Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shanghai Changhai Hospital
RECRUITING
Shanghai
Contact Information
Primary
Shuxiong Zeng, M.D. Ph.D
zengshuxiong@126.com
+8618930568759
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 72
Treatments
Experimental: Immediate GC chemotherapy infusion
For enrolled patients receiving immediate cisplatin/gemcitabine chemotherapy via intravenous infusion within 24 hours post transurethral resection of bladder tumor (TURBT), fluid samples were collected before and after TURBT, as well as post-chemotherapy, for UroCAD testing to assess chromosomal instability status and evaluate postoperative tumor residual changes. Subsequently, following EAU guidelines, patients were administered 1 year of intravesical Bacillus Calmette-Guérin (BCG) induction and maintenance therapy, with regular imaging studies and cystoscopic examinations for follow-up to assess the patients' pathological response status.
Related Therapeutic Areas
Sponsors
Leads: Changhai Hospital

This content was sourced from clinicaltrials.gov

Similar Clinical Trials