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

NCT06227065 · tracked via the Priya Life Science Switzerland tracker

Sponsor

Hospital Centre Biel/Bienne

Phase

Phase 2

Started

2026-12-01

Last updated

2026-09-18

Condition(s) studied

Bladder CancerNon-muscle Invasive Bladder CancerLow Grade

Investigational drug(s) / intervention(s)

Epirubicin →Mitomycin →Gemcitabine →Docetaxel →

Epirubicin: In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times. Epirubicin will be used as a concentrate for injection/instillation 2 mg/ml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg/ml of Epirubicin.

Mitomycin: In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times. Mitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions

Gemcitabine: In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times. Gemcitabine will be used as 2000 mg/50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg/50ml used for instillation.

Docetaxel: In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times. Docetaxel will be used as 140mg/7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg/ml by a total volume of the instillation solution of 50,7.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Pathological response — 15 weeks
Rate of patients that show complete pathological response to neoadjuvant chemoresection

Trial sites (2)

Facility	City	Region	Status
Lindenhofspital, Klinik für Urologie	Bern	Switzerland
Spitalzentrum Biel, Klinik für Urologie	Biel	Switzerland

Other trials for the same condition

T1G3R-1 Trial: Detectability and Prognostic Value of ctDNA in T1 G3 Bladder Cancer Recruiting

Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC Active, not recruiting

The Role of Preoperative Immunonutrition on Morbidity and Immune Response After Cystectomy (INCyst Trial) Recruiting

Guiding Instillation in Non Muscle-invasive Bladder Cancer Based on Drug Screens in Patient Derived Organoids Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06227065 on ClinicalTrials.gov ↗ ← All trials in Switzerland