To evaluate the efficacy and safety of the combination therapy of SH006 injection in the treatment of advanced hepatocellular carcinoma
This is an open, randomized, multicenter study aimed at evaluating the safety and efficacy of SH006 injection (15 mg/kg) in combination with bevacizumab and/or oxaliplatin/capecitabine versus regorafenib in the treatment of patients with advanced hepatocellular carcinoma
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle
85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle
Nanjing Tianyinshan Hospital
Nanjing, Jiangsu, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Progression-free Survival (PFS) (Phase II)
PFS was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).
Time frame: Up to approximately 4 years
Incidence of Adverse Events (AEs) (Phase II)
An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.
Time frame: Up to approximately 4 years
Overall Survival (OS) (Phase III)
OS was defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 4 years
Objective Response Rate (ORR)
ORR was assessed by investigators per RECIST 1.1
Time frame: Up to approximately 4 years
Disease Control Rate (DCR)
DCR was assessed by investigators per RECIST 1.1
Time frame: Up to approximately 4 years
Duration of Response (DOR)
DOR was assessed by investigators per RECIST 1.1
Time frame: Up to approximately 4 years
Time to progression (TTP)
TTP was assessed by investigators per RECIST 1.1
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1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle
160 mg orally once daily for 21 days continuous dosing followed by a 7-day break of each 28-day cycle
Time frame: Up to approximately 4 years