The goal of this clinical trial is to learn if the neoadjuvant therapy of iIparomlimab and Tuvonralimab plus lenvatinib works to treat hepatocellular carcinoma(HCC) patients with high risk of recurrence. It will also learn about the safety of the combination of iIparomlimab and Tuvonralimab plus lenvatinib. The main questions it aims to answer are:
Does the combination therapy improve the major pathological response rate and reduce the risk of disease recurrence or progression in HCC patients? What medical problems do participants have when taking this combination regimen? Researchers will compare this combination to previous studies to evaluate its efficacy and safety in managing HCC.
Participants will:
Take iIparomlimab and Tuvonralimab every 3 weeks for three times and lenvatinib everyday for 9 weeks.
Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms and the number of times when taking the combination regimen.
The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up
Be at least 18 years old at the time of signing the informed consent form, with no gender restrictions.
Hepatocellular carcinoma diagnosed by histology or imaging
At least one measurable lesion (according to the requirements of RECIST version 1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10mm or the short diameter of the enlarged lymph node is ≥15mm)
Have received any systemic treatment
ECOG score >1
Definite extrahepatic metastasis
Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
Single group
Lenvatinib
Drugdaily,8mg/ day for less than 60kg, 12mg/ day for more than 60kg, for 9 weeks
Iparomlimab and Tuvonralimab
Drug7.5mg/kg, every 3 weeks, for 3cycles.
Major Pathological response
Overall survival
Recurrence free survival
Disease control rate
objective remission rate
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