Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
Status:
Not yet recruiting
Trial end date:
2026-03-01
Target enrollment:
Participant gender:
Summary
This is a multicentre randomised 3-arm phase II clinical trial in patients with resectable
Hepatocellular Carcinoma (HCC). Sixty patients will be randomized 1:1:1 to 6 weeks of
pre-operative therapy with: pembrolizumab, lenvatinib or the combination of pembrolizumab and
lenvatinib followed by up to 12 months treatment with post-operative pembrolizumab. The aim
of the study is to compare the efficacy of pembrolizumab combined with lenvatinib with that
of pembrolizumab and lenvatinib alone in terms of major pathological response in patients
with resectable HCC. Major pathological response will be defined by the proportion of
patients with less than 10% viable tumour at resection.