HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma

Sponsor
Sun Yat-sen University
Study ID
NCT06333561
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Hepatic arterial infusion chemotherapy — PROCEDURE
    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.
  • Lenvatinib — DRUG
    12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
  • Tislelizumab — DRUG
    200mg intravenously every 3 weeks
  • Toripalimab — DRUG
    240mg intravenously every 3 weeks
  • Sintilimab — DRUG
    200mg intravenously every 3 weeks
  • Camrelizumab — DRUG
    200mg intravenously every 3 weeks

Study Details

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.

Key Dates

Start date
Jan 1, 2021
Status verified
Feb 2025
Primary completion
Dec 30, 2024
Completion
Dec 30, 2025

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: HAIC+Len+PD-1 inhibitor group
    HAIC combined with Lenatinib and PD-1 inhibitor group
  • Arm: Len group
    Lenvatinib alone

Primary Outcome Measure

Overall survival [ Time Frame: 24 months ]

Central Contacts

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