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

Sun Yat-sen University

Status: Enrolling

Conditions: Hepatic Arterial Infusion Chemotherapy; PD-1 Inhibitor; Hepatocellular Carcinoma; Lenvatinib

Treatments: Drug: Sintilimab; Drug: Tislelizumab; Drug: Camrelizumab; Procedure: Hepatic arterial infusion chemotherapy; Drug: Toripalimab; Drug: Lenvatinib

Study type: Observational

Funder types: Other

Identifiers

NCT06333561

Liver Project 7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

HAIC+Len+PD-1 inhibitor group

Description:

HAIC combined with Lenatinib and PD-1 inhibitor group

Treatment:

Drug: Lenvatinib

Drug: Toripalimab

Procedure: Hepatic arterial infusion chemotherapy

Drug: Camrelizumab

Drug: Tislelizumab

Drug: Sintilimab

Len group

Description:

Lenvatinib alone

Treatment:

Drug: Lenvatinib