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

Recruiting

• Conditions: Lenvatinib; Hepatocellular Carcinoma; PD-1 Inhibitor; Hepatic Arterial Infusion Chemotherapy
• Interventions: Procedure: Hepatic arterial infusion chemotherapy; Drug: Lenvatinib; Drug: Tislelizumab; Drug: Toripalimab; Drug: Sintilimab; Drug: Camrelizumab

• Registration Number: NCT06333561
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-27
• Primary Completion: 2024-12-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-06
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HAIC+Len+PD-1 inhibitor group	Hepatic arterial infusion chemotherapy	HAIC combined with Lenatinib and PD-1 inhibitor group
HAIC+Len+PD-1 inhibitor group	Lenvatinib	HAIC combined with Lenatinib and PD-1 inhibitor group
HAIC+Len+PD-1 inhibitor group	Tislelizumab	HAIC combined with Lenatinib and PD-1 inhibitor group
HAIC+Len+PD-1 inhibitor group	Toripalimab	HAIC combined with Lenatinib and PD-1 inhibitor group
HAIC+Len+PD-1 inhibitor group	Sintilimab	HAIC combined with Lenatinib and PD-1 inhibitor group
Len group	Lenvatinib	Lenvatinib alone
HAIC+Len+PD-1 inhibitor group	Camrelizumab	HAIC combined with Lenatinib and PD-1 inhibitor group

Primary Outcome Measures

Name	Time	Method
Overall survival	24 months	OS is the length of time from the date of inclusion until death from any cause.

Secondary Outcome Measures

Name	Time	Method
Progression-Free-Survival	12 months	Progression was defined as progressive disease by independent radiologic review

Trial Locations

Locations (1)

Chinese PLA General hospital; 🇨🇳 Beijing, Beijing, China