HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
Sun Yat-sen University
300 participants
Jan 1, 2021
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- primary infiltrative HCC according to MRI or CT imaging characteristics.
- Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Lenvatinib as initial treatment.
- patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
- no history of other malignancies.
- no tumor thrombus in the atrium or vena cava.
Exclusion Criteria6
- HCC with tumor capsule.
- under 18 years or over 75 years.
- TACE as initial treatment.
- sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
- incomplete tumor imaging data.
- lost to follow-up after treatment within three months.
Interventions
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
Locations(1)
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NCT06333561