Phase 1 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:

• Adults aged 19 years or older (male or female)
• People who have been diagnosed with advanced liver cancer (hepatocellular carcinoma) confirmed by imaging, tissue sample, or fluid sample, whose cancer has continued to grow despite standard treatments, or who cannot tolerate the available standard treatments
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage B or C; those with stage B must have had their cancer progress after surgery, liver transplant, or certain local treatments, or must not be eligible for those treatments
• People with a Child-Pugh score of A (5–6), which reflects relatively well-preserved liver function (confirm with trial site)
• People who have at least one measurable tumour that has not previously been treated with local therapy — or, if it has been treated locally, the tumour has since grown by 20% or more
• People with a general health performance rating of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations on physical activity (confirm with trial site)
• People with a life expectancy of at least 12 weeks
• People whose recent blood test results meet all of the following: adequate white blood cell counts, platelet count, and haemoglobin levels; normal or near-normal kidney function; liver enzyme levels within an acceptable range; bilirubin levels within an acceptable range; and normal or near-normal blood clotting function — provided no blood transfusions or certain growth factor injections were given in the 14 days before testing
• People who have been fully informed about the trial and have voluntarily agreed in writing to take part

Who may not be able to join:

• People with a known serious allergy or sensitivity to the trial drug or any of its ingredients, or to similar types of drugs
• People with a condition that makes swallowing tablets difficult or that affects how the body absorbs oral medication (such as coeliac disease, Crohn's disease, or prior surgery removing part of the intestine that affects absorption)
• People who have had another type of primary cancer diagnosed within the past 3 years — though certain cancers (such as some skin cancers, localised prostate cancer, papillary thyroid cancer, or cervical pre-cancer) may be acceptable if the treating doctor confirms they were successfully cured
• People who have had radiation, chemoembolisation, or radiofrequency ablation to the liver within the past 4 weeks
• People who have had major surgery within the past 4 weeks, or minor surgery within the past 2 weeks
• People who have had a significant heart rhythm problem, heart attack, unstable chest pain, or severe heart failure within the past 6 months
• People who have had a serious stroke or other significant brain blood vessel event within the past 6 months
• People who have had a blood clot in the lungs or legs, or a serious lung condition such as severe asthma, obstructive lung disease, or acute lung failure within the past 6 months
• People with brain or central nervous system metastases that are causing symptoms or are not stable — though those whose brain metastases have been stable for at least 4 weeks, confirmed by repeated imaging and clinical review, may be considered
• People with significant abnormalities on an electrocardiogram (heart tracing), as determined by the treating doctor
• People with uncontrolled high blood pressure (systolic above 140 mmHg or diastolic above 90 mmHg)
• People with a serious active infection requiring treatment — though people with hepatitis B (where viral activity is undetectable) or hepatitis C (where antiviral treatment is not currently needed) may be considered
• People with an active autoimmune disease that requires systemic (whole-body) treatment
• People with a known HIV infection
• People with symptoms from fluid build-up in the abdomen or around the lungs — though those who have been treated and are now clinically stable may be considered
• People with high levels of protein in the urine (Grade 3 or above, meaning 3.5 g or more per 24 hours)
• People with any other condition that the investigator believes could affect the interpretation of the trial results
• People who have received anticancer treatment (such as chemotherapy, targeted therapy, hormone therapy, or radiotherapy) within the past 4 weeks
• People who have received a live vaccine within the past 4 weeks
• People who have taken certain strong medications that affect how the trial drug is processed by the body (strong CYP1A2 inhibitors) within the past 2 weeks
• People who have previously had a bone marrow transplant or solid organ transplant from a donor
• Women who are pregnant or breastfeeding
• Men or women who are able to have children and are unwilling to use effective contraception — from enrolment until at least 6 months after the last dose (for women) or 3 months after the last dose (for men)
• People who still have side effects from previous cancer treatment that have not returned to a mild level (Grade 1 or below), except for hair loss
• People who are unable to have contrast-enhanced CT or MRI scans
• People who have taken part in another clinical trial and received an investigational drug or device within the past 4 weeks
• People who are otherwise considered unsuitable for participation, based on the treating doctor's judgement

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