The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) in combination with PD-1 inhibitors and Lenvatinib in patients with intermediate or advanced-stage hepatocellular carcinoma (HCC) after failure of systemic therapy recommended by BCLC.
Study Type
OBSERVATIONAL
Enrollment
84
Hepatic arterial infusion chemotherapy including FOLFOX and RALOX
PD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
The first hospital of China medical university
Shenyang, Liaoning, China
RECRUITINGOverall survival
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
Time frame: Up to approximately 2 years
Progression free survival(PFS) (Overall)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease (according to mRECIST) or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Progression free survival(PFS) of intra-hepatic lesions
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of intra-hepatic lesions or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Progression free survival(PFS) of extra-hepatic lesions
The PFS is defined as the time from the initiation of any combination treatment to the first documented appearance of extra-hepatic lesions or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Progression free survival(PFS) of portal vein tumor thrombus (PVTT)
The PFS is defined as the time from the initiation of any combination treatment to the first documented progressive disease of PVTT or death due to any cause, whichever occurs first.
Time frame: Up to approximately 2 years
Objective response rate(ORR) per RESCIST 1.1
The ORR is defined as the proportion of patients with a documented complete response(CR) or partial response(PR) per RECIST 1.1.
Time frame: Up to approximately 2 years
ORR per mRECIST
The ORR is defined as the proportion of patients with a documented CR or PR per mRECIST.
Time frame: Up to approximately 2 years
ORR of PVTT
The ORR is defined as the proportion of patients with a documented CR or PR of PVTT.
Time frame: Up to approximately 2 years
Adverse event(AE) per Common Terminology Criteria for Adverse Events(CTCAE) 5.0
The percentage and degree of patients who experience at least one AE, whether or not considered related to the treatment, according to CTCAE version 5.0.
Time frame: Up to approximately 2 years
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