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.
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…
Contacts
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