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 liver cancer (hepatocellular carcinoma, or HCC) that has spread or cannot be surgically removed, confirmed by imaging, tissue sample, or cell sample
• People who have already received at least 2 rounds of a first-line immunotherapy combination (specifically atezolizumab + bevacizumab, ipilimumab + nivolumab, or durvalumab + tremelimumab) and whose cancer has continued to grow despite that treatment
• People who have at least one measurable area of cancer in the liver that can be tracked on imaging scans, according to standard measurement guidelines
• People whose cancer cannot be treated with curative surgery or local treatments aimed at removing or destroying the tumour
• People who are reasonably active and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1), assessed within 7 days before joining the trial
• People with a life expectancy of at least 3 months
• People aged 19 years or older at the time of signing the consent form
• People who are able to understand and agree to the study requirements and sign a consent form voluntarily before the study begins
• People whose blood counts and liver and kidney function meet specific minimum levels (without having needed a blood transfusion or growth factor support in the 7 days before joining), including sufficient red blood cells, white blood cells, and platelets, and acceptable liver enzyme, bilirubin, kidney, and clotting levels (confirm specific values with the trial site)
• People whose liver function is rated as Child-Pugh class A within 7 days before joining the trial
• People who test negative for HIV at screening
• People whose hepatitis B (HBV) and hepatitis C (HCV) status has been confirmed at screening; people with active HBV must have a low viral load and be willing to take antiviral medication throughout the study; people with past or active HCV must have no detectable virus in their blood
• People whose side effects from previous cancer treatment have mostly resolved (to a mild level or lower) before joining, except for hair loss
• People with a past history of bleeding from stomach or oesophageal varices may be considered eligible if they have received appropriate treatment, have had no recurrent bleeding for at least 6 months, have no high-risk signs on a recent scope examination, and are currently assessed as low risk for further bleeding
• Women who are post-menopausal, or women of childbearing potential who agree to use a highly effective form of contraception from screening until at least 6 months after the last dose of study treatment, and who test negative for pregnancy at screening and within 72 hours before the first dose
• Women who agree not to breastfeed from the time of consent and for at least 6 months after the last dose of study treatment
• Men who have had a confirmed vasectomy, or men who agree to use effective contraception including condoms from screening until at least 3 months after the last dose, and who agree not to donate sperm during the study or for at least 3 months after stopping the study drug

Who may not be able to join:

• People who have already received more than one prior systemic (whole-body) treatment for their liver cancer
• People whose first-line treatment was anything other than one of the approved immunotherapy combinations listed above
• People who previously received a targeted therapy drug (such as lenvatinib, regorafenib, or cabozantinib) as part of their first-line treatment combination
• People who have had a known allergic reaction to lenvatinib or any of its ingredients
• People whose liver cancer is of certain less common types, specifically fibrolamellar HCC, sarcomatoid HCC, or a combined HCC and bile duct cancer (iCCA)
• People whose cancer has spread to the brain or central nervous system
• People who have a severe form of blood clotting in the main vein of the liver (called VP4 portal vein tumour thrombosis)
• People who have had significant heart problems within the 3 months before joining, including severe heart failure, unstable chest pain, a heart attack, or a serious abnormal heart rhythm
• People who have an abnormal heart electrical reading (a prolonged QTcF interval of more than 470 milliseconds) at screening
• People who have previously had a stem cell transplant or a solid organ transplant
• People who have an active infection requiring treatment, including active tuberculosis, within 14 days before the first dose
• People who have had major surgery within 3 weeks before joining, or who are planned to have surgery during the study
• People who have had another active cancer in the past 3 years, with some exceptions for certain early-stage or fully treated skin cancers and other cancers with no recurrence for 3 or more years (confirm with trial site)
• People who have required a procedure to treat stomach or oesophageal varices within 28 days before joining
• People who have bleeding or clotting disorders, or who are taking blood thinners that require regular INR monitoring (such as warfarin); certain other blood thinners that do not require INR monitoring are permitted
• People with uncontrolled high blood pressure (above 160/100 mmHg) despite appropriate medication, or whose blood pressure has not been stable in the week before screening
• People who have visible fluid build-up in the abdomen (ascites) that can be detected on a physical examination, regardless of severity; fluid seen only on imaging scans that is being managed with diuretics and a low-salt diet may be acceptable if liver function is rated Child-Pugh A (confirm with trial site)
• People who have had episodes of confusion or brain dysfunction related to liver disease (hepatic encephalopathy) in the 6 months before joining, or who currently have this condition
• People who are currently taking certain medications that are broken down by a specific liver enzyme (CYP3A4) and have a narrow safe dosing range, unless those medications can be stopped at least 5 half-lives before the first dose (confirm specific medications with the trial site)
• People who are currently taking certain medications that strongly block specific drug transport proteins (P-glycoprotein and/or BCRP)
• People who have significant amounts of protein in their urine above a specific threshold at screening
• People who have had serious blood vessel problems (such as a large aortic aneurysm or recent arterial blood clot) within the 6 months before starting treatment
• People who have received any other cancer treatment for liver cancer within 4 weeks before the first dose
• People who have received any other experimental treatment within 4 weeks before screening
• People who are currently enrolled in another clinical trial using an experimental drug
• People who are unable to swallow tablets or capsules, or who have digestive conditions that would prevent the study drug from being properly absorbed
• People with any other condition that, in the treating doctor's judgement, would prevent safe participation or make it difficult to follow the study procedures

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