OncoMatch/Clinical Trials/NCT05185739
Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
Is NCT05185739 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab and Lenvatinib for hepatocellular carcinoma.
Treatment: Pembrolizumab · Lenvatinib · Pembrolizumab and Lenvatinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: systemic chemotherapy
Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
Cannot have received: anti-VEGF therapy
Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
Cannot have received: systemic investigational anticancer agents
Has received any systemic chemotherapy, including anti-VEGF therapy, or any systemic investigational anticancer agents for advanced/unresectable HCC.
Cannot have received: local therapy
Has received local therapy including trans arterial embolic, chemo- or radiotherapy, external beam radiotherapy or ablative therapy to the measurable lesion to be resected.
Cannot have received: anti-PD-1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137).
Cannot have received: anti-PD-L1 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137).
Cannot have received: anti-PD-L2 therapy
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137).
Cannot have received: checkpoint inhibitor
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, or CD137).
Lab requirements
Blood counts
Haemoglobin (Hb) > 90g/l; Neutrophil Count > 1.5 x 10^9/l; Platelets > 75 x 10^9/l
Kidney function
GFR >40ml/min using a validated creatinine clearance calculation (e.g. Cockcroft-Gault or Wright formula)
Liver function
Child-Pugh A liver disease; ALT or AST < 5.0 x ULN; Albumin >32g/l; Amylase ≤ 1.5 x ULN; INR ≤1.4
Cardiac function
Left ventricular ejection fraction (LVEF) below the institutional normal range as determined by MUGA or ECHO [excluded]; Prolongation of QTc interval to > 480 ms [excluded]
Child-Pugh A liver disease; INR ≤1.4; Haemoglobin (Hb) > 90g/l; Neutrophil Count > 1.5 x 10^9/l; Platelets > 75 x 10^9/l; GFR >40ml/min; ALT or AST < 5.0 x ULN; Albumin >32g/l; Amylase ≤ 1.5 x ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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