This study will evaluate efficacy and safety of Toripalimab Injection (JS001) with or without Lenvatinib as a Neoadjuvant Therapy in patients with Resectable Hepatocellular Carcinoma (HCC)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Given IV
Given IV 4 mg capsules
Given IV 4 mg capsules
Fudan University Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Pathological response rate
CPR,MPR
Time frame: Up to 2 months
Objective response rate
ORR is defined as the percentage of participants who achieved CR or PR
Time frame: up to 2 months
Percentage of R0 resection
Used for assessment of the feasibility of the neoadjuvant therapy.
Time frame: up to 8 months
Time to operation
Used for assessment of the feasibility of the neoadjuvant therapy.
Time frame: up to 8 months
Progression free survival
Used for assessment of the efficacy.
Time frame: up to 3 years
Overall survival
Used for assessment of the efficacy.
Time frame: up to 3 years
Incidence of adverse events
Graded using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Safety will be recorded through the incidence of adverse events, serious adverse events and specific laboratory abnormalities (worst grade) in each treatment arm.
Time frame: up to 3 years
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