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NCT06227065Not yet recruiting

Precise Chemoresection in Low-grade NMIBC Using Drug Screens in Patient-derived Organoids

Summary

Based on the unmet clinical need to reduce invasiveness of treatment of low grade NMIBC, the investigators conduct this prospective, open label, single arm and single center phase II trial. The investigators aim to use drug screens in PDOs to guide neoadjuvant intravesical instillation therapy with either Epirubicin, Mitomycin C, Gemcitabine or Docetaxel to achieve chemoresection NMIBC.

Inclusion criteria

1. Signed Informed Consent Form 2. Age ≥ 18 years 3. Primary or recurrent NMIBC suspected to be low-grade or maximum G2 with a negative urine cytology

Exclusion criteria

1. Anticoagulation other than acetylsalicylic acid 2. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol as judged by the investigator 3. Severe infection within 4 weeks prior to the date of the patient's informed consent signature 4. Contraindication for frequent catheterization 5. Pregnancy or nursing. Female subject of childbearing potential (defined as premenopausal women who have not undergone surgical sterilization and are sexually active with a male part-ner) must have a negative urine pregnancy test at screening 6. Female subject of childbearing potential who is unwilling to use effective contraception method(s) from the start of the intravesical instillation with the IMP until six months after the last instillation 7. Male subject who is unwilling to use an effective contraception method from the start of the intravesical instillation with the IMP until four months after the last instillation 8. Vulnerable individual, e.g., individual incapable of judgement or currently incarcerated or oth-erwise institutionalized (prisoner), or refugee 9. Concomitant participation in another interventional clinical trial with an active treatment within 4 weeks prior to the date of the patient's informed consent signature and during the current trial.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Not yet recruiting
Phase
Phase 2
Study type
Interventional
Countries
Switzerland
Sponsor
Hospital Centre Biel/Bienne(Other)
Protocol no.
SZB-URO-26-001
Conditions
Bladder Cancer, Non-muscle Invasive Bladder Cancer, Low Grade
Interventions
Drug

Treatments studied

  • Epirubicin
  • Mitomycin
  • Gemcitabine
  • Docetaxel

Collaborators

Spitalzentrum Biel, Lindenhofgruppe AG, Fond'action contre le cancer

Locations · 2

  • Bern, SwitzerlandLindenhofspital, Klinik für UrologieNot yet recruiting at this site
  • Biel, SwitzerlandSpitalzentrum Biel, Klinik für UrologieNot yet recruiting at this site

In total, worldwide, both sites listed in the registry are planned; recruitment has not opened yet.

Site status per the ClinicalTrials.gov registry (last update posted: September 18, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.