This ia a single-arm, single-center, not-randomized, open-label phase II study. The purpose of this study is to evaluate the efficacy and safety of Sintilimab (PD-1 antibody) combined with Lenvatinib(TKI) for the treatment of local advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
200mg intravenously every 3 weeks
12 mg (or 8 mg) once daily (QD) oral dosing.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGObjective Response Rate (ORR)
Time frame: 1 year after the last patient's enrollment
Overall Survival
Time frame: 2 years after the last patient's enrollment
Safety of combination sintilimab and lenvatinib as evaluated by incidence of adverse events(AEs), serious adverse events (SAEs).
Time frame: 2 years after the last patient's enrollment
Conversion rate to surgery
Conversion rate defined as the proportion of participants be able to receive surgery after the initiation of the study treatment
Time frame: 1 year after the last patient's enrollment
Tumor mutation burden in association with ORR and survival.
It will be performed by NGS.
Time frame: 1 year after the last patient's enrollment
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