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

Last updated: February 5, 2025
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disorders

Cancer/tumors

Hepatic Fibrosis

Treatment

Tislelizumab

Lenvatinib

Sintilimab

Clinical Study ID

NCT06333561
Liver Project 7
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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 receivedLenvatinib alone in Len group.

  5. no history of other malignancies.

  6. no tumor thrombus in the atrium or vena cava.

Exclusion

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 Design

Total Participants: 300
Treatment Group(s): 6
Primary Treatment: Tislelizumab
Phase:
Study Start date:
January 01, 2021
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Chinese PLA General hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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