Sun Yat-Sen Treatment Strategy for Enhancing Response in 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
This is a multicenter, prospective, open-label, Phase II, four-arm parallel study evaluating the efficacy and safety of different sensitization strategies combined with disitamab vedotin and toripalimab in patients with HER2-positive muscle-invasive urothelial carcinoma of the bladder (MIBC). Eligible patients with cT2-4aN0M0 HER2-positive urothelial carcinoma of the bladder will receive neoadjuvant disitamab vedotin plus toripalimab in combination with one of four sensitizing agents: sitagliptin, tazemetostat, tafolecimab, or ursodeoxycholic acid. After six cycles of neoadjuvant treatment, patients will undergo comprehensive response assessment, including imaging, cystoscopy, urine cytology, and complete transurethral resection of bladder tumor (cTURBT). Patients who achieve a clinical complete response (cCR) may enter a bladder-preservation treatment pathway, including additional disitamab vedotin plus toripalimab and subsequent toripalimab maintenance therapy. Patients who do not achieve cCR will be considered for salvage radical cystectomy. The primary objective is to evaluate the cCR rate of each treatment strategy. Secondary objectives include bladder-intact disease-free survival, overall survival, bladder preservation rate, safety, quality of life, treatment costs, and exploratory biomarker analyses.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18 lat lub więcej
- •Potwierdzona histologicznie zmiana nowotworowa w pęcherzu moczowym (stadium T2-T4a, bez przerzutów)
- •Ekspresja białka HER2 w komórkach nowotworu
- •Ogólny stan zdrowia pozwalający na uczestnictwo w badaniu (ECOG 0-1)
- •Prawidłowe wyniki badań krwi: liczba białych krwinek, płytki krwi, hemoglobina
- •Prawidłowa funkcja wątroby i nerek
- •Zdolność do tolerowania zabiegu chirurgicznego
- •Zgoda na stosowanie antykoncepcji (dla kobiet w wieku rozrodczym)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 21, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Sun Yat-sen Memorial Hospital
Guangzhou, China
Trial contact
Wenlong Zhong, Professor
Mingli Luo, Doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/22/2026.
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