The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
SHR-1826 will be administrated per dose level in which the patients are assigned.
SHR-1826 and immunotherapy will be administrated per dose level in which the patients are assigned.
Shanghai Zhongshan Hospital
Shanghai, China
Objective Response Rate (ORR) by RECIST V1.1
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by RECIST V1.1.
Time frame: up 2 years
Objective Response Rate (ORR) by mRECIST
The ORR is defined as complete remission (CR) rate + partial remission (PR) rate by mRECIST.
Time frame: up 2 years
Disease control rate (DCR) by RECIST V1.1
The DCR is defined as complete remission (CR) rate + partial remission (PR) rate + stable disease (SD).
Time frame: up 2 years
Progression-free survival (PFS)
The PFS is defined as Time from the date of enrollment to of disease.
Time frame: up 2 years
Overall survival (OS)
The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Time frame: up 2 years
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