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This study evaluated the safety and efficacy of SHR-8068 in combination with Adebrelimab and other anti-tumor drugs in the treatment of advanced renal cell carcinoma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-8068+ Adebrelimab + Bevacizumab | Experimental |
| |
| SHR-8068+ Adebrelimab +HS-10516 | Experimental |
| |
| SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-8068;Adebrelimab ;Bevacizumab | Drug | SHR-8068+ Adebrelimab + Bevacizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | DLT defined as the Incidence and severity of adverse events | 21days after the first administration of each subject |
| Overall response rate(ORR) | Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator | from first dose to disease progression or death, whichever comes first, up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) by investigator | Defined as time from first administration until progression or death as assessed by the investigator | Until progression or death, assessed up to approximately 3 year |
| Duration of response (DOR) by investigator assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuting Wang | Contact | +021-61053363 | yuting.wang@hengrui.com | |
| Liang Hu | Contact | 18036618148 | Liang.hu@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| SHR-8068;Adebrelimab ;HS-10516 | Drug | SHR-8068+ Adebrelimab +HS-10516 |
|
| SHR-8068; Adebrelimab ; Bevacizumab ;HRS-10516 | Drug | SHR-8068+ Adebrelimab + Bevacizumab +HRS-10516 |
|
Defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death assessed by the investigator |
| Until progression or death, assessed up to approximately 3 year |
| Disease control rate (DCR) by investigator assessment | Defined as percentage of participants who achieved a best overall response of complete response (CR), partial response (PR) or stable disease (SD) assessed by the investigator | Until progression, assessed up to approximately 3 year |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | until to 90 days after the last dose,assessed up to approximately 3 years |