Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelim… (NCT06879145) | Clinical Trial Compass
RecruitingPhase 2/3
Clinical Study on the Treatment of MIBC Patients With SHR-A2102 Injection Combined With Adebrelimab (SHR-1316)
China840 participantsStarted 2025-04-25
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Received systemic anti-tumor therapy 4 weeks before starting the study treatment
✕. The toxicity and/or complications of previous anti-tumor treatments have not recovered to NCI-CTCAE ≤ 1 level
✕. Subjects known or suspected to have interstitial pneumonia
✕. Individuals with any active, known or suspected autoimmune diseases
✕. There are clinical symptoms or diseases of the heart that have not been well controlled
✕. Diagnosed with any other malignant tumor
✕. Subjects who have experienced severe infections within 28 days prior to their first medication use
What they're measuring
1
Phase II: pCR evaluated by researchers;
Timeframe: Three months after the last subject underwent RC+PLD surgery
2
Phase III: EFS assessed by BICRï¼›
Timeframe: 5 years after the first medication of the last subject