Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Have a diagnosis of Hepatocellular Carcinoma (HCC) confirmed by radiology, histology, or cytology (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible) and suitable for surgical resection. Radiological confirmation of diagnosis is provided by the study site and defined by the presence of a liver mass of at least 1 cm and exhibiting arterial hypervascularity with washout in the portal venous phase seen in a tri-phasic magnetic resonance imaging (MRI). 2. Measurable disease based on RECIST 1.1 3. HCC amenable to R0 resection with curable intent 4. Child-Pugh A liver disease 5. International normalised ratio (INR) ≤1.4 6. ECOG Performance status 0 or 1 7. Adequate haematological function as defined by: * Haemoglobin (Hb) \> 90g/l * Neutrophil Count \> 1.5 x 109/l * Platelets \> 75 x 109/l 8. Adequate renal function with GFR \>40ml/min using a validated creatinine clearance calculation (e.g. Cockcroft-Gault or Wright formula) 9. Adequa