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.
Has a diagnosis of HCC confirmed by radiology, histology, or cytology;
Barcelona Clinic Liver Cancer (BCLC) stage C with the presence of portal vein tumor thrombus;
Has received previous systemic therapy recommended for HCC by BCLC, and the systemic therapy failed;
Both PD-1inhibitors and Lenvatinib patients received only include marketed drugs but are not limited to HCC approval;
The interval between the failure of systemic therapy and the beginning of combination therapy longer than 3 months;
With other malignant tumors;
Unable to meet criteria of combination timeframe described above.
Patients with intermediate or advanced HCC who have failed in systemic therapy recommended by BCLC and received HAIC in combination with PD-1 inhibitors and Lenvatinib under real-world practice conditions.
Cohort
Retrospective
hepatic artery infusion chemotherapy
Procedure/SurgeryHepatic arterial infusion chemotherapy including FOLFOX and RALOX
Lenvatinib + PD-1 monoclonal antibody
DrugPD-1 inhibitors including Camrelizumab, Sintilimab, Tislelizumab
Overall survival
The OS is defined as the time from the initiation of any combination treatment to death due to any cause.
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.
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.
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.
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.
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