EV + Toripalimab vs GC as Neoadjuvant Therapy in Locally Advanced/High-Risk MIBC

Recruiting Phase 2 Interventional Study
Muscle-Invasive Bladder Cancer (MIBC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
58 (estimated)
Sponsor
Peking University Third Hospital · Other
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About This Trial
The purpose of this Phase II, open-label, multicenter, randomized controlled study is to evaluate the efficacy and safety of Enfortumab Vedotin in combination with Toripalimab compared to Gemcitabine plus Cisplatin. This regimen is evaluated as a neoadjuvant treatment for patients with locally advanced or high-risk muscle-invasive bladder cancer. Participants will be randomly assigned in a 1:1 rat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Voluntarily agree to participate in the study and sign the informed consent form (ICF). * Age ≥ 18 and ≤ 80 years at the time of signing the ICF. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically confirmed muscle-invasive urothelial car…
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