This study evaluated the safety and efficacy of SHR-8068 in combination anti-tumor drugs in the treatment of advanced renal cell carcinoma
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
SHR-8068+ Adebrelimab + Bevacizumab
SHR-8068+ SHR-4610
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGDose-limiting toxicity (DLT)
DLT defined as the Incidence and severity of adverse events
Time frame: 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
Time frame: from first dose to disease progression or death, whichever comes first, up to 3 years
Progression-free survival (PFS) by investigator
Defined as time from first administration until progression or death as assessed by the investigator
Time frame: Until progression or death, assessed up to approximately 3 year
Duration of response (DOR) by investigator assessment
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
Time frame: 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
Time frame: 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
Time frame: until to 90 days after the last dose,assessed up to approximately 3 years
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