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 b

Trial Details

NCT ID
NCT05185739
Phase
PHASE2
Sponsor
University College, London
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • Pembrolizumab
  • Lenvatinib
  • Pembrolizumab and Lenvatinib
Locations (sample)
  • Birmingham, United Kingdom|52.48142,-1.89983
  • Cambridge, United Kingdom|52.2,0.11667
  • Edinburgh, United Kingdom|55.95206,-3.19648
  • Glasgow, United Kingdom|55.86515,-4.25763
  • Leeds, United Kingdom|53.79648,-1.54785

Key Eligibility Criteria

  • Have a diagnosis of Hepatocellular Carcinoma (HCC) confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangio…
  • Measurable disease based on RECIST 1.1
  • HCC amenable to R0 resection with curable intent
  • Child-Pugh A liver disease

For full eligibility, visit ClinicalTrials.gov.

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