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 are able to understand and sign a voluntary consent form before any trial procedures begin, and who are willing to attend study visits and follow the study schedule.
• People aged 19 or older at the time of signing the consent form.
• People who have been diagnosed with advanced or inoperable liver cancer (HCC) that cannot be treated with surgery or local treatments, confirmed by tissue or cell testing, and whose tissue sample from the primary liver tumour shows a positive result for a protein called FGF19 overexpression.
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C, with a Child-Pugh score of 5 or 6, no signs of brain confusion caused by liver disease (hepatic encephalopathy), and no significant fluid build-up in the abdomen requiring medical treatment (confirm with trial site).
• People who have at least one measurable tumour that can be tracked during the trial, including those who have had prior local treatments such as ablation or embolisation, provided the target tumour was not treated locally or has since shown signs of growth after local treatment.
• People with a general health performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor restrictions on physical activity.
• People with a life expectancy of at least 3 months.
• People whose blood tests, taken within 14 days before the first treatment, show that their blood counts and organ function meet the required levels — including adequate white blood cells, platelets, haemoglobin, liver function, kidney function, and clotting measures (confirm specific values with trial site).
• People who are not pregnant or breastfeeding, and who agree to use effective contraception during the trial and for up to 6 months after the last dose. Women of childbearing potential must also have a negative pregnancy blood test within 14 days before the first dose.

Who may not be able to join:

• People who have previously received systemic chemotherapy or anti-cancer drug treatments for advanced or inoperable liver cancer — except those who received exactly one cycle of Atezolizumab plus Bevacizumab.
• People who have previously received immune checkpoint therapy (such as anti-PD-1 or anti-PD-L1 drugs) — except those who received exactly one cycle of Atezolizumab plus Bevacizumab.
• People who have previously been treated with FGFR inhibitors, including selective FGFR4 or pan-FGFR inhibitor drugs.
• People who received local liver treatments (such as chemoembolisation, radiation, or ablation) within 4 weeks before the first dose of trial treatment.
• People who had major surgery, significant radiotherapy, or other local-regional cancer treatments within 4 weeks before starting the trial, or anti-hormonal cancer therapy within 2 weeks before starting.
• People who still have side effects from previous cancer treatments that have not recovered to a mild level (Grade 1 or lower), with some exceptions such as hair loss or stable thyroid conditions managed with medication (confirm exceptions with trial site).
• People currently taking certain medications that interact with specific liver enzymes (CYP3A4) or drug transport pathways (P-gp), including some foods such as grapefruit, pomelo, starfruit, and Seville oranges, within 14 days before the first dose.
• People who have taken systemic steroid or immune-suppressing medications within 2 weeks before starting the trial, or who are expected to need them during the trial, with limited exceptions (confirm with trial site).
• People who have received a live or weakened vaccine within 4 weeks before the first dose or plan to receive one during the trial (inactivated vaccines such as flu shots or COVID-19 vaccines may be permitted — confirm with trial site).
• People who regularly take non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen daily; occasional use for symptoms like headaches may be permitted (confirm with trial site).
• People with an active infection, unexplained fever above 38.5°C, or who have been on antibiotic treatment within 2 weeks before the first dose.
• People diagnosed with certain rare or mixed types of liver cancer, including fibrolamellar carcinoma, sarcomatoid HCC, or mixed hepatocellular cholangiocarcinoma.
• People with known active cancer spread to the brain or central nervous system.
• People whose cancer is affecting major airways or large blood vessels, or where there is a large tumour mass near the centre of the chest (confirm with trial site); those with tumour involvement in portal or hepatic veins may still be considered.
• People with fluid build-up in the abdomen, around the lungs, or around the heart that needed medical draining within 2 weeks before the first dose.
• People with a history of hepatic encephalopathy (brain confusion caused by liver disease).
• People whose liver tumour makes up 50% or more of the total liver volume.
• People with a severe type of blood clot in the portal vein (Vp4 or beyond, including the inferior vena cava) (confirm with trial site).
• People with untreated or insufficiently treated swollen veins in the oesophagus or stomach that are bleeding or at high risk of bleeding, or who had a bleeding event from these veins within 6 months before starting the trial.
• People who had a core biopsy or minor surgical procedure (other than placement of a vascular access device) within 3 days before the first Bevacizumab dose.
• People with a history of abnormal openings between organs (fistula), a hole in the gastrointestinal tract (perforation), or an abdominal abscess within 6 months before starting the trial.
• People who have had another cancer diagnosis within the past 5 years, with some exceptions for low-risk conditions such as certain treated skin cancers or early-stage localised cancers (confirm with trial site).
• People with known allergies or severe reactions to any ingredients in the trial drugs, or to certain antibody-based medicines or products derived from Chinese hamster ovary cells.
• People with a history of autoimmune diseases (conditions where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease, among others — though some well-controlled conditions such as Type 1 diabetes on insulin, autoimmune-related hypothyroidism on thyroid replacement, or certain mild skin conditions not needing systemic treatment may still be considered (confirm with trial site).
• People whose heart's electrical activity shows a prolonged QTcF interval (above 470 ms on average across three ECG readings) or other significant heart rhythm abnormalities identified by their doctor.
• People whose heart pumping function (left ventricular ejection fraction) is below 50%.
• People with significant heart conditions, including severe heart failure (New York Heart Association Class III or IV), unstable chest pain, a heart attack within the past 6 months, heart rhythm problems requiring treatment, or uncontrolled high blood pressure (systolic at or above 150 mmHg and/or diastolic at or above 100 mmHg).
• People who have had significant blood vessel disease, such as an aortic aneurysm or recent arterial blood clot, within 6 months before starting the trial.
• People with a serious active or ongoing infection requiring systemic antibiotic or antiviral treatment (excluding hepatitis, which is covered separately).
• People with a history of immune system deficiency, a positive HIV test result, active tuberculosis, or other conditions affecting immune function.
• People with hepatitis B (HBV) infection whose HBV-DNA levels are at or above 2000 IU/mL within 14 days before starting the trial; those with lower viral levels on appropriate antiviral treatment may be considered (confirm with trial site).
• People who have both hepatitis B and hepatitis C infection at the same time.
• People with active hepatitis C infection (with detectable HCV-RNA levels), or who would need hepatitis C treatment at the same time as the trial treatment.
• People with any other significant health conditions — such as serious breathing, hormonal, metabolic, or nervous system problems, or mental health or social circumstances — that the treating doctor believes could affect safety or the ability to follow the trial requirements.
• People who have had an allogeneic stem cell transplant or an organ transplant.
• People who have coughed up significant amounts of blood (2.5 mL or more in one episode) within 1 month before starting the trial.
• People with known bleeding disorders or significant problems with blood clotting (not related to anticoagulant medication use).
• People currently taking high-dose aspirin (more than 325 mg per day) or certain blood-thinning or anti-clotting medications such as clopidogrel or dipyridamole within 10 days before starting the trial.
• People currently on full-dose blood-thinning or clot-dissolving medication for treatment purposes (rather than prevention) within 10 days before starting the trial; low-dose preventive anticoagulation to keep a vascular access device open may be permitted under certain conditions (confirm with trial site).
• People with serious wounds that are not healing, active ulcers, or untreated bone fractures.
• People who are unable to swallow oral medication or who have conditions affecting how the body absorbs oral medication, such as removal of the entire stomach, short bowel syndrome, active diarrhoea, or severe irritable bowel syndrome requiring medication.

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