Clinical trial NCT06333561: HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
Official title: Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma
Lenvatinib
PD-1 Inhibitor
Hepatic Arterial Infusion Chemotherapy
Keywords: Hepatic arterial infusion chemotherapy
Tislelizumab
Toripalimab
Sintilimab
Camrelizumab
Lenvatinib
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

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.

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.

Primary outcomes:
measure: Overall survival
timeFrame: 24 months
Secondary outcomes:
measure: Progression-Free-Survival
timeFrame: 12 months
Other outcomes:
measure: Objective response rate
timeFrame: 6 months
Locations:
city: Beijing
country: China
facility: Chinese PLA General hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Feng Duan, MD
role: PRINCIPAL_INVESTIGATOR
References: