The purpose of this study is to assess the difference of safety and efficacy about PD-1 Antibody and Lenvatinib Plus transcatheter arterial chemoembolization (TACE) on downstaging hepatocellular carcinoma with BCLC B/C.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE ): Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.
Huashan hospital
Shanghai, Shanghai Municipality, China
RECRUITINGResection rate
Resction rate refers to the proportion of patients who can receive radical surgery after downstaging treatment.
Time frame: 6 months after downstaging treatment
Adverse events (safety)
Postoperative adverse events (safety ) will be evaluated according to the NCI CTCAE Version 4.03.The number and severity of treatment-related side effects, including AE and SAE, will be recorded during treatment.
Time frame: 6 months
Overall survival (OS)
The duration from the date of recruitment to the date of death from any cause.
Time frame: 2 years
Objective response rate (ORR)
ORR is defined as the percentage of participants who have a confirmed complete response or partial response according to RECIST 1.1 or mRECIST.
Time frame: 6 months
Progression free survival (PFS)
PFS is defined as the time from enrollment of the trial to the first documented disease progression or death due to any cause.
Time frame: 6 months
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