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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

Inclusion Criteria:

  1. primary infiltrative HCC according to MRI or CT imaging characteristics.
  2. Child-Pugh class A or B, and Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
  3. Lenvatinib as initial treatment.
  4. patients received HAIC and PD-1 inhibitor in HAIC+Len+PD-1 group, patients received Lenvatinib alone in Len group.
  5. no history of other malignancies.
  6. no tumor thrombus in the atrium or vena cava.

Exclusion Criteria:

  1. HCC with tumor capsule.
  2. under 18 years or over 75 years.
  3. TACE as initial treatment.
  4. sorafenib or other systemic therapy with or without PD-1 inhibitor following HAIC.
  5. incomplete tumor imaging data.
  6. lost to follow-up after treatment within three months.

Study details
    Hepatocellular Carcinoma
    Lenvatinib
    PD-1 Inhibitor
    Hepatic Arterial Infusion Chemotherapy

NCT06333561

Sun Yat-sen University

15 October 2025

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