HAIC Combine With Lenvatinib and Camrelizumab for Advanced HCC With PVTT

  • End date
    Dec 22, 2024
  • participants needed
  • sponsor
    Peking University
Updated on 22 March 2022


The purpose of this study is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy combined with Lenvatinib and Camrelizumab compared to Lenvatinib plus Camrelizumab for advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT).


Hepatic arterial infusion chemotherapy (HAIC) can significantly improve the local drug concentration in liver compared to systemic chemotherapy. The efficacy of HAIC for hepatocellular (HCC), cholangiocarcinoma, gallbladder, and colorectal carcinoma liver metastasis has been proved by many published studies. HAIC with oxaliplatin and 5-fluorouracil could significantly prolong survival time for HCC patients with portal vein tumor thrombosis (PVTT). Lenvatinib, as a new oral anti-neovascularity inhibitor, was proved to have similar efficacy in HCC patients compared to sorafenib in REFLECT study. The sub-group analysis showed that the median overall survival (OS) in Lenvatinib group was significantly longer that sorafenib group in Chinese HCC patients. As a programmed death-1 inhibitor, Camrelizumab showed its efficacy in advanced HCC patients as second-line therapy, with the 6-month survival rate of 74.7%, median progression-free survival (PFS) of 2.1 months, and median OS of 14.4 months. Thus, the investigators carried out this prospective controlled trial to compare the efficacy and safety of HAIC combined with Lenvatinib and Camrelizumab and Lenvatinib and Camrelizumab for advanced HCC with PVTT.

Total 66 subjects will be recruited in this trial, each group of 33 subjects in treatment group (HAIC-Cola group) and control group (Cola group). The primary endpoint is six-month progression-free survival rate, and the secondary endpoints are OS, overall response rate (ORR), PFS, time-to-progression (TTP) and safety. The safety evaluation will be carried out according to the standard of adverse reaction classification (Common Terminology Criteria for Adverse Events, CTCAE v5.0).

Condition Hepatocellular Carcinoma, Portal Vein Thrombosis
Treatment HAIC, Lenvatinib 1, Camrelizumab 1, Lenvatinib 2, Camrelizumab 2
Clinical Study IdentifierNCT05166239
SponsorPeking University
Last Modified on22 March 2022


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