Immediate chemotherapy after bladder tumor removal for high-risk patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of administering immediate systemic chemotherapy following the surgical resection of high-risk non-muscle-invasive bladder cancer (NMIBC). The focus is on patients who have undergone transurethral resection of bladder tumors (TURBT) and are at risk of residual tumors that could lead to recurrence. By using a regimen of gemcitabine and cisplatin within 24 hours post-surgery, the study aims to eliminate floating tumor cells and reduce the likelihood of cancer returning. The trial is prospective and single-arm, meaning all participants will receive the same treatment without a control group.

Why it matters

Who can join: the full rules

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

Where it's running

• Shanghai Changhai Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Shuxiong Zeng, M.D. Ph.D — Department of Urology, Changhai Hospital, Naval Medical University, Shanghai, China
• Study coordinator: Shuxiong Zeng, M.D. Ph.D
• Email: zengshuxiong@126.com
• Phone: +8618930568759

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 1-Year Recurrence After En Bloc Resection for Large Bladder Tumors

  This trial tests whether en bloc resection of bladder tumors larger than 2.5 cm can reduce recurrence compared with standard transurethral resection in adults with non-muscle invasive bladder cancer.

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• Feasibility of automatic, laser-based distance control in people with superficial bladder tumors

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• NMIBC sample collection to test cancer monitoring biomarkers

  This study tests a blood, urine, and tumor tissue collection approach in people with high-risk non-muscle invasive bladder cancer to see if a molecular test can detect residual disease and monitor recurrence.

  Recruiting Natera, Inc. · Austin, Texas · NCT07763197

• Intravesical UGN-501 for Recurrent NMIBC (Phase 1, dose-escalation)

  This study tests whether UGN-501 can be safely given into the bladder to treat adults with recurrent non-muscle invasive bladder cancer.

  Recruiting at 6 sites Phase 1 UroGen Pharma Ltd. · Queen Creek, Arizona and 14 other locations · NCT07725796

• Shr-1501 plus BCG vs physician-chosen chemotherapy for BCG-unresponsive non-muscle invasive bladder cancer

  This study tests whether SHR-1501 given with BCG works better than the doctor-selected chemotherapy for people with BCG-unresponsive non-muscle invasive bladder cancer.

  Recruiting at 2 sites Phase 3 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07424287

• Disitamab Vedotin plus BCG vs BCG alone in HER2-expressing high-risk NMIBC

  This study tests whether adding disitamab vedotin to BCG helps people with early, high-risk bladder cancer that hasn’t spread outside the bladder.

  Recruiting Phase 3 Fudan University · Shanghai, Shanghai Municipality · NCT07207824

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.