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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
840
Treatment with SHR-A2102 in combination with fixed dose Adebrelimab
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGPhase II: pCR evaluated by researchers;
Time frame: Three months after the last subject underwent RC+PLD surgery
Phase III: EFS assessed by BICR;
Time frame: 5 years after the first medication of the last subject
ORR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
DCR
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
pCR
Time frame: Three months after MIBC surgery
EFS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
DFS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
OS
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
R0 resection rate
Time frame: One month after the last subject underwent RC+PLD surgery
AE
Time frame: from Day1 to 90 days after last dose
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