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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with SHR-A2102 in combination with a fixed dose of Adebrelimab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-A2102ï¼›Adebrelimab | Drug | Treatment with SHR-A2102 in combination with fixed dose Adebrelimab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase II: pCR evaluated by researchers; | Three months after the last subject underwent RC+PLD surgery | |
| Phase III: EFS assessed by BICRï¼› | 5 years after the first medication of the last subject |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | from first dose to disease progression or death, whichever comes first, up to 3 years | |
| DCR | from first dose to disease progression or death, whichever comes first, up to 3 years | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoxue Pi | Contact | 0518-82342973 | xiaoxue.pi@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| pCR |
| Three months after MIBC surgery |
| EFS | from first dose to disease progression or death, whichever comes first, up to 3 years |
| DFS | from first dose to disease progression or death, whichever comes first, up to 3 years |
| OS | from first dose to disease progression or death, whichever comes first, up to 3 years |
| R0 resection rate | One month after the last subject underwent RC+PLD surgery |
| AE | from Day1 to 90 days after last dose |