A Randomized, Open, Multicenter Phase II/III Clinical Study of SHR-A2102 for Injection Combined With Adebrelimab (SHR-1316) in Perioperative Treatment of Muscular Invasive Bladder Cancer (MIBC)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age over 18 years old, gender not limited.
• The patient voluntarily joined this study and signed informed consent
• ECOG score is 0 or 1
• Expected survival period ≥ 2 years.
• Pathology and imaging diagnosis of non metastatic muscle invasive bladder cancer
• There are assessable lesions that meet the RECIST 1.1 criteria
• Enough organ function
Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Xiaoxue Pi
xiaoxue.pi@hengrui.com
0518-82342973
Time Frame
Start Date: 2025-04-25
Estimated Completion Date: 2031-12
Participants
Target number of participants: 840
Treatments
Experimental: Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab
Related Therapeutic Areas
Sponsors
Leads: Suzhou Suncadia Biopharmaceuticals Co., Ltd.