Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)

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.

NCT Number	NCT05185739
Lead Sponsor	University College, London Collaborators: Merck Sharp & Dohme LLC
Conditions	Hepatocellular Carcinoma
Enrollment	60 participants
Start Date	2022-08-25
Primary Completion	2028-07 (estimated)
Study Completion	2030-07 (estimated)
Updated on ClinicalTrials.gov	2024-12-06