Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
Chief Investigator:
Prof Tim Meyer
Recruitment target:
EudraCT number:
Contact details:
Lay summary:
Perioperative pembrolizumab and lenvatinib in Resectable Hepatocellular Carcinoma (HCC)

This is a randomised phase II study in patients withresectable hepatocellular carcinoma (HCC). Sixty patients from across the UK willbe randomised 1:1:1 and this trial is looking at giving pembrolizumab andlenvatinib before surgery for people with liver cancer.


Before surgery patients will have one of the following:

Cohort 1: pembrolizumab by it self (200mg IV every 3 weeks) for two cycles (6 weeks)

Cohort 2: lenvatinib by it self (8 or 12mg PO once daily according to weight

Cohort 3: combination of pembrolizumab and lenvatinib at the standard doses for 6 weeks

Surgery will take place in a 14-day window between day 50 and day 63 from the start of treatment. Between 8-12 weeks following surgery, all patients will begin treatment with pembrolizumab for up to 12 months.

After surgery everyone has to take pembrolizumab.

Key inclusion/exclusion criteria:

Key inclusion criteria:

  • have a type of liver cancer called hepatocellular carcinoma  
  • are able to have surgery to remove the cancer 
  • have  at least 1 area of cancer that the doctor can measure on a scan
  • are willing to have tissue samples taken
  • have a liver that is working normally.
  • are able to swallow capsules
  • have satisfactory blood test results
  • are fully active but might not be able to do heavy physical work (performance status 0 or 1)
  • are willing to use contraception during treatment and for a time after if there is any chance you or your partner could become pregnant
  • are at least 18 years old
  • Low risk of death resulting from surgery surgical morbidity and mortality from liver surgery as defined by the following criteria:

               -   Single tumour

               -  Vascular resection not needed.

               -  Expected remaining residual liver volume 40%

                Non-cirrhotic (No scarring of the liver)

                                  o   Single tumour any size

                 Cirrhotic (scarring of the liver)

                                  o   Major surgery to take out part of the organ (up to 5 segments) only with good liver function as defined locally by:

                                  o   Normal Bilirubin and

                                  o   No enlarged veins that that may be found in the oesophagus in people with cirrhosis of the liver on pre-operative CT

Duration of recruitment: 24 months

The aims of the trial are to find out: 

•             how well thesetreatments work

•             whether thesetreatments reduce the chances of liver cancer returning after surgery

•             what the sideeffects are and if they are manageable

•             whether the sideeffects might delay surgery

Treatment lasts for up to 18 months.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
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