A Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants With Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
The goal of this clinical trial is to learn if the drug Alpha1H works to treat low-to-intermediate risk non-muscle-invasive bladder cancer in adults. It will also learn about the safety of drug Alpha1H. The main questions it aims to answer are: * Does giving drug Alpha1H before surgery lower the risk of cancer returning or worsening compared to standard care alone? * Is drug Alpha1H safe and well-tolerated by participants? Researchers will compare participants receiving drug Alpha1H before standard surgery to participants receiving standard care alone to see if drug Alpha1H lowers the risk of cancer returning or progressing. Participants will: * Be randomly assigned to receive either drug Alpha1H before surgery or standard care alone. * Receive drug Alpha1H directly into the bladder 6 times over about 1 month if assigned to the Alpha1H group. * Hold the liquid in the bladder for up to 2 hours during each visit. * Undergo standard surgery through the urethra (TURBT) to remove remaining tumor tissue. * Visit the clinic regularly for follow-up checkups (including bladder examinations and urine tests) to check if the cancer returns. * Fill out questionnaires about their quality of life.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Rak pęcherza moczowego niskiego lub pośredniego ryzyka (bez naciekania w głębokie warstwy)
- •Pierwszy guz lub guzów, które się powtarzają, małe (0,5-3 cm), niskiego stopnia zaawansowania
- •Zdolność przetrzymywania płynu w pęcherzu przez 2 godziny
- •Kobiety muszą poddać się testowi ciąży i używać antykoncepcji
- •Podpisana zgoda na udział w badaniu
✗ Disqualifies
- •Guz o nietypowym wyglądzie lub zaawansowany (T1 lub wysoki stopień zaawansowania)
- •Poprzednia terapia BCG bezpośrednio w pęcherzu
- •Inny nowotwór w ciągu ostatnich 5 lat (z wyjątkiem raków skóry)
- •Aktywna infekcja HIV, zapalenie wątroby B lub C
- •Poprzednia chemioterapia lub radioterapia
- •Zapalenie dróg moczowych wymagające antybiotyków
- •Udział w innym badaniu klinicznym w ciągu ostatniego miesiąca
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- September 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Fakultni nemocnice Motol a Homolka
Prague, Czechia
Trial contact
Catharina Svanborg, MD, PhD.
Petr Bouska
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/22/2026.
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