This study is conducted to evaluate the efficacy and safety of SHR-8068 combined with Adebrelimab and Apatinib compared with Adebrelimab combined with Apatinib in perioperative treatment of resectable hepatocellular carcinoma with intermediate or high recurrence risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
SHR-8068 injection.
Adebrelimab injection.
Apatinib mesylate tablets.
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China
Major pathological response (MPR (70%)) rate.
MPR (70%) is defined as residual viable tumor cells \<= 30% in the tumor bed.
Time frame: After surgery, approximately 3 months.
Event-free survival (EFS).
Time frame: From randomization to event, approximately 2 years.
12-month and 24-month Event-free survival (EFS) rate.
Time frame: From randomization to event, approximately 2 years.
R0 resection rate.
Time frame: After surgery, approximately 3 months.
Safety endpoints, including adverse events (AEs) and serious adverse events (SAEs) by NCI-CTCAE v6.0.
Time frame: Approximately 2 years.
Safety endpoints, including surgical complications by Clavien-Dindo.
Time frame: Approximately 2 years.
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