Hepatic arterial infusion chemotherapy (HAIC) plus lenvatinib and programmed cell death protein-1 (PD-1) inhibitor have shown promising results for advanced hepatocellular carcinoma (HCC). However, the evidence for infiltrative is limited. In this study, we aimed to describe the efficacy and safety of lenvatinib and PD-1 inhibitor with HAIC plus lenvatinib for infiltrative HCC.
This study is a multicenter, observational real-world study to explore the efficacy, safety of lenvatinib and PD-1 inhibitor with HAIC in advanced infiltrative hepatocellular carcinoma. This study focused on the management of locoregional therapy combined with lenvatinib and PD-1 inhibitor. This study will create a database that will provide clinical parameters and outcomes of patients undergoing HIAC combined lenvatinib and PD-1 inhibitor as standard of care in hopes of answering key clinical questions.
Study Type
OBSERVATIONAL
Enrollment
300
Hepatic arterial infusion chemotherapy (HAIC) procedure was performed with FOLFOX regimen: 85 or 135 mg/m2 oxaliplatin from hour 0 to 2 on day 1400 mg/m2 leucovorin from hour 2 to 4 on day 1, and 400 mg/m2 fluorouracil bolus at hour 5 on the day 1; and 2400 mg/m2 fluorouracil over 46 h on days 1 and 2.
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
200mg intravenously every 3 weeks
240mg intravenously every 3 weeks
200mg intravenously every 3 weeks
200mg intravenously every 3 weeks
Chinese PLA General hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall survival
OS is the length of time from the date of inclusion until death from any cause.
Time frame: 24 months
Progression-Free-Survival
Progression was defined as progressive disease by independent radiologic review
Time frame: 12 months
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