Phase 2 Liver Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have been diagnosed with a specific type of liver cancer called Hepatocellular Carcinoma (HCC) — confirmed by imaging, tissue sample, or cell sample — and whose cancer is considered suitable for surgical removal (note: certain subtypes called fibrolamellar and mixed hepatocellular/cholangiocarcinoma are not eligible)
• People whose cancer can be seen and measured on scans according to a standard set of measurement rules called RECIST 1.1
• People whose liver cancer can potentially be fully removed by surgery with the goal of cure
• People whose liver disease is classified as Child-Pugh A, meaning the liver is still functioning relatively well (confirm with trial site)
• People whose blood clotting measurement (INR) is 1.4 or below
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard scale used by doctors called the ECOG Performance Status scale
• People whose blood counts meet certain minimum levels — specifically, haemoglobin above 90g/l, neutrophil count above 1.5 x 10⁹/l, and platelet count above 75 x 10⁹/l
• People whose kidneys are working well enough, as measured by a kidney function calculation giving a result above 40ml/min
• People whose liver function blood test results fall within acceptable ranges — specifically, liver enzymes (ALT or AST) below 5 times the upper limit of normal, albumin above 32g/l, and amylase at or below 1.5 times the upper limit of normal
• People with a past or ongoing hepatitis C infection, provided the virus is undetectable at screening and any curative antiviral treatment was completed at least 4 weeks before joining the trial
• People with hepatitis B that is being controlled with antiviral treatment for at least 4 weeks and with a viral load below 500 IU/mL, or people with certain hepatitis B antibody profiles and a viral load below 500 IU/mL who may not need antiviral treatment (confirm with trial site)
• People aged 18 or older
• People with a life expectancy of more than 3 months
• People who are willing and able to give written consent to participate
• People who are able to swallow tablets or capsules
• People who are willing to use effective contraception during the study and for 120 days after the last dose of study treatment

Who may not be able to join:

• People who have previously received systemic chemotherapy, anti-VEGF therapy, or any other systemic investigational cancer treatment for advanced or inoperable liver cancer
• People who have received local treatments — such as arterial therapies, chemotherapy delivered directly to the liver, radiation, or ablation — to the specific liver lesion intended for surgical removal
• People who have previously been treated with certain types of immunotherapy drugs that work on immune checkpoint pathways, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar agents
• People who have had bleeding from oesophageal or stomach varices (enlarged veins) within the past 6 months
• People who have received a live vaccine within 30 days before registering for the trial (non-live seasonal flu vaccines are permitted)
• People who have an active autoimmune disease that has required systemic treatment — such as disease-modifying drugs, steroids, or immunosuppressants — within the past 2 years (some conditions such as vitiligo, psoriasis, and certain stable thyroid conditions may be exceptions — confirm with trial site)
• People who have a history of, or currently have, non-infectious lung inflammation (pneumonitis or interstitial lung disease) that required steroid treatment
• People who have been diagnosed with an immune deficiency condition, or who are taking steroid medications above a certain dose or other immunosuppressive drugs within 7 days before starting treatment
• People who have, or have recently been treated for, another cancer within the past 3 years (some skin cancers and carcinomas in situ that have been treated with curative intent may be exceptions — confirm with trial site)
• People who have uncontrolled fluid build-up in the abdomen (ascites) that cannot be managed with medication
• People with uncontrolled high blood pressure (above 150/90 mmHg) where medications have not been adjusted within 1 week before joining the trial
• People who have been diagnosed with a condition causing confusion due to liver disease (hepatic encephalopathy) within the past 6 months
• People who are unable to have any form of contrast-enhanced imaging scans (such as CT or MRI with contrast dye)
• People who have a digestive condition that may affect how the body absorbs oral medication, including certain bowel conditions or previous bowel surgery
• People who have a pre-existing severe (Grade 3 or higher) fistula (an abnormal connection between internal body parts) in the digestive system or elsewhere
• People who have had significant coughing up of blood or tumour bleeding within 2 weeks before starting treatment
• People who have uncorrected abnormal electrolyte (salt) levels in their blood
• People who have had significant heart problems within the past 12 months, including severe heart failure, unstable angina, a heart attack, a stroke within the past 6 months, or a heart rhythm problem requiring treatment
• People with a prolonged heart electrical interval (QTc greater than 480 ms) on a heart tracing (ECG)
• People whose heart pumping function (left ventricular ejection fraction) is below the normal range as measured by a heart scan
• People who are at high risk of serious bleeding or clotting disorders, or who are taking blood-thinning medications that require INR monitoring (such as warfarin)
• People with significant levels of protein in their urine, unless a 24-hour urine test shows the amount is below 1g per day
• People who have not adequately recovered from side effects of previous cancer treatments or from complications of major surgery
• People who have had major surgery to the liver before starting treatment
• People who have had minor surgery within 7 days before starting treatment
• People who have a serious wound, ulcer, or bone fracture that has not healed
• People with a known history of HIV infection
• People who have an active infection currently requiring systemic treatment (excluding hepatitis B and C)
• People who have had a severe allergic reaction (Grade 3 or higher) to pembrolizumab or lenvatinib, or to any of their ingredients
• People who have both active hepatitis B and active hepatitis C infections at the same time
• People who have both active hepatitis B and active hepatitis D infections at the same time
• People with a known history of active tuberculosis
• People with a known psychiatric condition or substance use disorder that would prevent them from being able to participate fully in the trial
• People who are currently participating in, or have participated in, another clinical trial involving an investigational treatment within 4 weeks before the first dose (some exceptions may apply — confirm with trial site)
• People who have had an organ or tissue transplant from another person
• People who are pregnant or breastfeeding
• People whose cancer has spread outside the liver or has grown into major blood vessels

Important: Always verify eligibility with the trial site directly before applying.