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

Recruiting now

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

In brief

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 facts

Study ID

NCT06333561

Run by

Sun Yat-sen University

People needed

300

Starts

2021-01-01

Expected to finish

2025-12-30

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Chinese PLA General hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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