An Exploratory Study on the Neoadjuvant Therapy of iIparomlimab and Tuvonralimab Combined With Lenvatinib for Hepatocellular Carcinoma
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)
• No systematic treatment has been received before
• CNLC：Ib to IIIa
• There is at least one of the following high-risk factors for postoperative recurrence: AFP\>400ng/ml; Single tumor \>5cm; The number of tumors is greater than 3 or any one of them is greater than 3cm; There are vascular tumor thrombus or tumors adjacent to large blood vessels, etc.
• The ECOG score was 0-1 within one week before enrollment
• Hematology and organ functions are adequate
• Fertile women: Agree to abstain from sex (avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1% during the treatment period and for at least 6 months after the last administration