Clinical trial

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

Name

Liver Project 7

Description

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.

Trial arms

Trial start

2021-01-01

Estimated PCD

2024-12-30

Trial end

2024-12-30

Status

Recruiting

Treatment

Hepatic arterial infusion chemotherapy

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.

Arms:

HAIC+Len+PD-1 inhibitor group

Lenvatinib

12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day

Arms:

HAIC+Len+PD-1 inhibitor group, Len group

Tislelizumab

200mg intravenously every 3 weeks

Arms:

HAIC+Len+PD-1 inhibitor group

Toripalimab

240mg intravenously every 3 weeks

Arms:

HAIC+Len+PD-1 inhibitor group

Sintilimab

200mg intravenously every 3 weeks

Arms:

HAIC+Len+PD-1 inhibitor group

Camrelizumab

200mg intravenously every 3 weeks

Arms:

HAIC+Len+PD-1 inhibitor group

Size

300

Primary endpoint

Overall survival

24 months

Eligibility criteria

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.

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 300, 'type': 'ESTIMATED'}}

Updated at

2024-03-27

1 organization

1 product

2 drugs

4 indications

Organization

Sun Yat-sen University

Product

Lenvatinib

Indication

Hepatocellular Carcinoma