RecruitingNCT06333561

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

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


Sponsor

Sun Yat-sen University

Enrollment

300 participants

Start Date

Jan 1, 2021

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether combining three treatments — a targeted chemotherapy delivered directly into the liver (HAIC), a targeted drug called lenvatinib, and an immune checkpoint inhibitor (a PD-1 blocker) — works better than lenvatinib alone for a specific, aggressive form of liver cancer called infiltrative hepatocellular carcinoma. **You may be eligible if...** - You have been diagnosed with infiltrative liver cancer (HCC) confirmed by MRI or CT scan - You are between 18 and 75 years old - Your liver function is relatively preserved (Child-Pugh class A or B) - You have not received prior systemic therapy for this cancer - You have a good functional status (able to carry out daily activities with little limitation) **You may NOT be eligible if...** - Your liver cancer has a defined tumor capsule around it - You have had another cancer in the past - The cancer has spread into the heart chambers or major blood vessels - You have had sorafenib or other systemic treatments before Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREHepatic 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.

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


Locations(1)

Chinese PLA General hospital

Beijing, Beijing Municipality, China

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NCT06333561


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