HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hepatic arterial infusion chemotherapy, Lenvatinib, Tislelizumab, Toripalimab.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitor, Hepatic Arterial Infusion Chemotherapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of HAIC Combined With Lenvatinib and PD-1 Inhibitor in Infiltrative Hepatocellular Carcinoma: an Observational, Real-world Study
Overview
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.
Interventions
- Procedure 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. - Drug Lenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day - Drug Tislelizumab
200mg intravenously every 3 weeks - Drug Toripalimab
240mg intravenously every 3 weeks - Drug Sintilimab
200mg intravenously every 3 weeks - Drug Camrelizumab
200mg intravenously every 3 weeks
Primary outcome measures
- Overall survival [Time frame: 24 months]
Secondary outcome measures (1)
- Progression-Free-Survival [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Chinese PLA General hospital — Beijing
Identifiers
NCT: NCT06333561 · Liver Project 7