Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
Recruiting
Phase 2
Phase 3
Interventional Study
Muscular Invasive Bladder Cancer (MIBC)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
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 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 840 (estimated)
- Sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
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About This Trial
In phase II, the main objective is to evaluate the efficacy of SHR-A2102 combined with Adebrelimab in the treatment of muscular invasive bladder cancer (MIBC); The main objective of phase III is to evaluate the efficacy of SHR-A2102 for injection combined with Adebrelimab compared with gemcitabine combined with cisplatin in the treatment of muscular invasive bladder cancer (MIBC).
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
\- 1.18-80 years old, gender not limited. 2.The patient voluntarily joined this study and signed informed consent 3.ECOG score is 0 or 1 4.Expected survival period ≥ 2 years. 5.Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer 6.There are assessabl…
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