NCT06889623Recruiting
Immediate Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer
Impact of Immediate Cisplatin/Gemcitabine Chemotherapy Following Resection for High-Risk Non-Muscle-Invasive Bladder Cancer: an Open-label, Single-arm, Prospective Trial
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 16 Mar 2025
- Start date
- 1 Jun 2024
- Primary completion date
- 1 Jun 2026
- Lead sponsor
- Changhai Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT06889623
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 1 Jun 2024 to the primary completion date, 1 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Incomplete tumor resection
- Concurrent upper urinary tract or prostatic urethral UC
- Previous systemic chemotherapy, immunotherapy, or radiotherapy
Other illness
- Bladder cancer other than UC
- MIBC or benign diseases
- Active infection
- Uncontrollable urinary tract infection
Lab values
- Serum creatinine greater than twice the normal level
Other
- Leukopenia/thrombocytopenia
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Changhai Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.