Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
ConditionNMIBC
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChanghai Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
High-grade T1
Any recurrent high-grade Ta
High-grade Ta & Tumor diameter greater than 3 cm or multifocal
Any CIS
Disqualifiers
Bladder cancer other than UC
MIBC or benign diseases
Incomplete tumor resection
Active infection
Trial design
Design model
Single group
Treatments tested in this trial
Immediate postoperative chemotherapy
Procedure/SurgerySystemic chemotherapy with cisplatin/gemcitabine intravenous infusion within 24 hours after TURBT
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: Immediate GC chemotherapy infusionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
One-year recurrence-free survival rate
The percentage of patients who remain cancer-free for one year after treatment.
Time frame
About two years after the first immediate chemotherapySecondary outcomes
1
Pathological downstaging rate
The percentage of patients whose cancer has decreased in stage following treatment.
Time frame
About 2-6 weeks after the first immediate chemotherapy2
The incidence of grade ≥ 3 adverse events（AEs）
The frequency of severe or serious side effects experienced by patients during a clinical trial or medical treatment(CTCAE V5.0 ).
Time frame
About two years after the first immediate chemotherapy3
UroCAD.MRD Index
Body fluid samples were collected from patients before and after TUBRT and chemotherapy for chromosomal instability testing, and the residual tumor status of patients was analyzed by analyzing the changes in the UroCAD.MRD index.
Time frame
TURBT perioperative period, about 15 daysSponsors and contacts
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Source ClinicalTrials.gov