Actively Recruiting
Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
Led by University College, London · Updated on 2024-12-06
60
Participants Needed
11
Research Sites
409 weeks
Total Duration
On this page
Sponsors
U
University College, London
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Perioperative Pembrolizumab and Lenvatinib in Resectable Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Hepatocellular Carcinoma confirmed by radiology, histology, or cytology, suitable for surgical removal
- Measurable tumor based on RECIST 1.1 criteria
- Tumor can be completely removed with curative intent (R0 resection)
- Child-Pugh class A liver disease
- International normalized ratio (INR) less than or equal to 1.4
- ECOG Performance status of 0 or 1
- Adequate blood counts: hemoglobin over 90 g/L, neutrophils over 1.5 x 10^9/L, platelets over 75 x 10^9/L
- Adequate kidney function with glomerular filtration rate over 40 ml/min
- Adequate liver function: ALT or AST less than 5 times upper limit, albumin over 32 g/L, amylase less than or equal to 1.5 times upper limit
- Undetectable hepatitis C viral load if previously infected and completed treatment at least 4 weeks before randomization
- Controlled hepatitis B with antiviral therapy for at least 4 weeks and viral load under 500 IU/mL
- Age 18 years or older
- Predicted life expectancy over 3 months
- Ability to swallow oral medication
- Willingness to use effective contraception during study and for 120 days after last dose
- Provided written informed consent
You will not qualify if you...
- Previous systemic chemotherapy or investigational cancer treatments for advanced or unresectable HCC
- Previous local therapies like embolization, chemo/radiotherapy, or ablation to the tumor to be removed
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or similar immune checkpoint inhibitors
- Recent esophageal or gastric variceal bleeding within 6 months
- Live vaccine received within 30 days before registration (except killed vaccines)
- Active autoimmune disease requiring systemic treatment in past 2 years, except stable thyroid conditions, vitiligo, or psoriasis
- History of pneumonitis or interstitial lung disease requiring steroids or current disease
- Immunodeficiency or current systemic steroid therapy over 10 mg daily prednisone equivalent
- Another progressing cancer requiring treatment within past 3 years, except certain skin and in situ cancers
- Uncontrolled ascites or uncontrolled high blood pressure
- Hepatic encephalopathy in last 6 months
- Contraindications to contrast imaging
- Gastrointestinal conditions affecting absorption of lenvatinib
- Severe gastrointestinal or other fistulas
- Recent significant bleeding or bleeding from tumor
- Electrolyte abnormalities not corrected
- Significant cardiovascular problems within 12 months before treatment
- Prolonged QTc interval over 480 ms
- Reduced heart function below normal institutional range
- Risk of severe bleeding or use of certain blood thinners
- High proteinuria unless quantitatively low on 24-hour urine
- Not recovered from toxicity or complications of prior cancer treatments or major surgery
- Major liver surgery prior to treatment without adequate recovery
- Minor surgery within 7 days before starting treatment
- Serious non-healing wounds or fractures
- HIV infection
- Active infection requiring systemic therapy (except HBV, HCV)
- Severe allergy to pembrolizumab or lenvatinib
- Dual active infections with hepatitis B and C or hepatitis D
- History of active tuberculosis
- Psychiatric or substance abuse disorders interfering with study participation
- Participation in another investigational study within 4 weeks before first dose
- Previous allogenic tissue or organ transplant
- Pregnant or breastfeeding women
- Any condition or therapy that could interfere with study results or participation
- Evidence of cancer spread outside the liver or major blood vessel invasion
AI-Screening
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Trial Site Locations
Total: 11 locations
1
Queen Elizabeth Hospital
Birmingham, United Kingdom
Actively Recruiting
2
Addenbrooke's Hospital
Cambridge, United Kingdom
Actively Recruiting
3
Western General Hospital
Edinburgh, United Kingdom, EH4 2XU
Not Yet Recruiting
4
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Not Yet Recruiting
5
St James's Hospital
Leeds, United Kingdom
Not Yet Recruiting
6
Clatterbridge Cancer Centre
Liverpool, United Kingdom
Not Yet Recruiting
7
Hammersmith Hospital
London, United Kingdom
Actively Recruiting
8
King's College Hospital
London, United Kingdom
Actively Recruiting
9
Royal Free Hospital
London, United Kingdom
Actively Recruiting
10
The Christie NHS Foundation Trust
Manchester, United Kingdom
Not Yet Recruiting
11
Freeman Hospital
Newcastle upon Tyne, United Kingdom
Actively Recruiting
Research Team
M
Michelle Hung
CONTACT
A
Alan Sahin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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