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NCT Number: NCT06333561

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatic Arterial Infusion Chemotherapy Lenvatinib Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial PD-1 Inhibitor

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Overall survival

    Time frame: 24 months

    OS is the length of time from the date of inclusion until death from any cause.

Secondary outcomes

  1. Progression-Free-Survival

    Time frame: 12 months

    Progression was defined as progressive disease by independent radiologic review

Other outcomes

  1. Objective response rate

    Time frame: 6 months

    ORR, as determined based on tumor response according to RECIST 1.1, is defined as the proportion of all included patients whose best overall response (BOR) is either a complete response or partial response.

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Duan, MD

CONTACT

[email protected]

86 13910984586

Qunfang Zhou, MD

CONTACT

[email protected]

86 19868000115

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Mar 27, 2024
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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