Phase 2 Bladder Cancer Trial, Recruiting NCT06388720 Sponsor: National Cancer Center, Korea Condition: Bladder Cancer
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Phase 2 Bladder Cancer Trial, Recruiting

NCT06388720
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 20 years of age or older
  • You are willing and able to sign a written consent form to participate in the study
  • You have been diagnosed with high-risk non-muscle-invasive bladder cancer (a type of bladder cancer that has not grown deep into the bladder wall) that has been confirmed by a tissue sample, and you have previously received BCG treatment (a common bladder cancer therapy)
  • Your most recent bladder examination or surgical procedure to remove bladder tumours was performed within the last 8 weeks before starting the trial treatment
  • Your high-risk bladder cancer did not respond to BCG treatment, even after receiving it properly
  • You are either not a suitable candidate for surgery to remove your bladder, or you have chosen not to have that surgery
  • You are not pregnant or breastfeeding during the study period

Who may not be able to join:

  • Your bladder cancer has grown into the muscle layer of the bladder wall (found during your last surgical procedure)
  • Scans show that you also have cancer in the upper parts of your urinary system (such as the kidneys or ureters)
  • Scans show that the cancer has spread outside the bladder
  • Scans show that cancer has spread to nearby lymph nodes (glands) or to other parts of the body
  • Your tissue sample shows that the cancer is mostly or entirely made up of certain rare types of cancer cells (confirm with trial site)
  • You have received chemotherapy through a drip or injection for another cancer within the last 3 years
  • You have had radiation therapy to the pelvic area for another cancer within the last 3 years
  • You have had Mitomycin-C or gemcitabine placed directly into your bladder within the last 3 years (there may be an exception for early use after surgery — confirm with trial site)
  • You have a known allergy to Mitomycin-C or gemcitabine
  • A camera examination of your bladder shows a tumour in the urethral area of the prostate
  • You are currently taking part in another clinical trial or have taken an experimental drug or device within the last 4 weeks
  • You received chemotherapy directly into your bladder after your last bladder procedure but before starting this trial
  • You have a condition that affects your blood's ability to clot, or you have low platelet levels
  • You are pregnant or breastfeeding
  • You have recently received a yellow fever vaccine or are taking the medication phenytoin
  • You have significant liver or kidney problems (confirm with trial site)
  • You have severe suppression of your bone marrow's ability to produce blood cells
  • You have a severe active infection
  • You have been definitively diagnosed with a scarring or inflammatory lung condition, confirmed by a chest X-ray
  • You have previously had radiation therapy to your chest

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Ho Kyung Seo, MD, National Cancer Center, Korea

Phone: 82-31-920-1678

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
National Cancer Center, Korea
Registry
ClinicalTrials.gov
Start date
19 November 2024
Est. completion
31 December 2027

Where this trial is recruiting

🇰🇷 South Korea

Primary endpoints

High risk Recurrent free survival in sequential treatment group.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov