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

ConditionsHepatocellular Carcinoma Lenvatinib PD-1 Inhibitor Hepatic Arterial Infusion Chemotherapy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-75

SponsorSun Yat-sen University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Hepatic arterial infusion chemotherapy
Procedure/Surgery
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

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: HAIC+Len+PD-1 inhibitor group6 interventions

Group B: Len group1 intervention

Trial outcomes

Primary outcomes

Overall survival

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

Time frame

24 months

Secondary outcomes

Progression-Free-Survival

Progression was defined as progressive disease by independent radiologic review

Time frame

12 months

Other outcomes

Objective response rate

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.

Time frame

6 months

Sponsors and contacts

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Sun Yat-sen University

Lead sponsor

Source ClinicalTrials.gov

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