Actively Recruiting
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-06-18
840
Participants Needed
1
Research Sites
344 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years old, any gender
- Voluntary participation with signed informed consent
- ECOG performance score of 0 or 1
- Expected survival of at least 2 years
- Diagnosed with non-metastatic muscle invasive bladder cancer by pathology and imaging
- Presence of measurable lesions meeting RECIST 1.1 criteria
- Adequate organ function
You will not qualify if you...
- Received systemic anti-tumor therapy within 4 weeks before study treatment
- Toxicity or complications from previous anti-tumor treatments not recovered to NCI-CTCAE grade 1 or less
- Known or suspected interstitial pneumonia
- Active or suspected autoimmune diseases
- Uncontrolled heart diseases
- Diagnosis of any other malignant tumor
- Severe infections within 28 days before first medication
- History of immunodeficiency
- Use of live attenuated vaccine within 28 days before first study medication
- Major surgery within 28 days before first medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xiaoxue Pi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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