Hepatocellular Carcinoma, Lenvatinib, PD-1 Inhibitor, Hepatic Arterial Infusion Chemotherapy
Conditions
Keywords
Hepatic arterial infusion chemotherapy, Tislelizumab, Toripalimab, Sintilimab, Camrelizumab, Lenvatinib
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.
Interventions
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.
DRUGLenvatinib
12 mg (body weight ≥60 kg) , 8 mg (body weight \<60 kg) orally once a day
DRUGTislelizumab
200mg intravenously every 3 weeks
DRUGToripalimab
240mg intravenously every 3 weeks
DRUGSintilimab
200mg intravenously every 3 weeks
DRUGCamrelizumab
200mg intravenously every 3 weeks
Sponsors
Sun Yat-sen University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 24 months | OS is the length of time from the date of inclusion until death from any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free-Survival | 12 months | Progression was defined as progressive disease by independent radiologic review |
Other
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate | 6 months | 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. |
Countries
China
Contacts
Primary ContactQunfang Zhou, MD
Backup ContactFeng Duan, MD
Outcome results
None listed