Phase II open label, multicenter study to evaluate the efficacy and safety of AK112 (PD-1/VEGF Bispecific) in patients with unresectable hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
IV infusion, specified dose on specified days
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Number of patients with Adverse Events (AEs)
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) Per RECIST v1.1
Time frame: Up to approximately 2 years
Objective Response Rate (ORR) Per mRECIST
Time frame: Up to approximately 2 years
Disease control rate (DCR)
Time frame: Up to approximately 2 years
Duration of Response (DoR)
Time frame: Up to approximately 2 years
Time to response (TTR)
Time frame: Up to approximately 2 years
Progression free survival (PFS)
Time frame: Up to approximately 2 years
Overall survival (OS)
Time frame: Up to approximately 2 years
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