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Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)

StatusRecruiting
PhasePhase 2/3
Started2025-04-25
View on ClinicalTrials.gov ↗

Amendment history

2026-07-09
Study Status, Eligibility v3
Eligibility criteria+11 characters
Inclusion Criteria: Age- over 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 assessable lesions that meet the RECIST 1.1 criteria 7. Enough organ function Exclusion Criteria: Received systemic [...]
2025-06-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05→confirmed 2025-04-25
Study sitesdetails revised at 1 of 1 site
2025-04-17
Study Status v1
Start date2025-03-31→2025-05
2025-03-11
Original filing
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 Details
NCT Number NCT06879145
Lead Sponsor Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Conditions Muscular Invasive Bladder Cancer (MIBC)
Enrollment 840 participants
Start Date 2025-04-25
Primary Completion 2031-12 (estimated)
Study Completion 2031-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-13