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 signed a consent form to participate in the study
• People aged 19 or older at the time of signing the consent form
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) based on standard Korean medical guidelines, either through tissue testing or clinical assessment
• People whose liver cancer cannot be surgically removed and/or has spread locally or to other parts of the body, with evidence that it has grown into major blood vessels near the liver (confirmed by specialised CT or MRI scans)
• People who have at least one tumour that can be measured using standard imaging guidelines (RECIST v1.1), including those who have had previous local treatments — such as tumour ablation or targeted radiation to the liver — provided at least one untreated measurable tumour remains, or a previously treated area has since shown signs of regrowth
• People whose liver is functioning at a level known as Child-Pugh class A (a measure of how well the liver is working)
• People who are generally well enough to carry out everyday activities, rated 0 or 1 on a standard health performance scale
• People whose blood test results from within the past 28 days meet the following minimum levels (confirm exact values with trial site): sufficient red blood cells, white blood cells, and platelets; acceptable liver function markers, bilirubin, albumin, and clotting time; and adequate kidney function
• People who have been tested for hepatitis B and C, and, if infected, are already receiving appropriate antiviral treatment
• People who are able and willing to use effective contraception or remain abstinent for at least 6 months after the last dose of the study drug (applies to both women who could become pregnant and men)

Who may not be able to join:

• People whose liver cancer is a specific rare subtype called fibrolamellar carcinoma or sarcomatoid carcinoma
• People who have already received two or more prior systemic (whole-body) drug treatments for advanced liver cancer
• People whose previous first-line systemic treatment did not include an immune checkpoint inhibitor-based therapy
• People who have previously had radiation therapy to the liver, particularly if the area being considered for this trial overlaps with a previously treated area
• People who received local liver treatments (such as ablation, embolisation, or liver-directed radiation) within the 28 days before starting the study, or who have not yet recovered from complications of such procedures (a shorter 7-day wait may apply for bone-directed palliative radiation — confirm with trial site)
• People with an active or past autoimmune condition or immune deficiency — such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease — with some exceptions for conditions that are well-controlled, such as stable thyroid conditions on hormone replacement, controlled type 1 diabetes managed with insulin, or a chronic skin condition not requiring systemic medication
• People who have previously received a bone marrow or solid organ transplant from another person
• People who are currently taking corticosteroids at a moderate-to-high dose or other immune-suppressing medications within 14 days before starting the study
• People with a history of severe allergic reactions to certain types of laboratory-made antibody treatments
• People with active cancer that has spread to the brain or the lining of the brain and spinal cord
• People with moderate to severe or hard-to-manage fluid build-up in the abdomen
• People with active hepatic encephalopathy (a condition where the liver is unable to remove toxins, affecting brain function)
• People who have had another type of cancer within the past 2 years, unless that cancer carried a very low risk of spreading or causing death (for example, cancers with a 5-year survival rate above 90%)
• People with serious uncontrolled health conditions, including significant heart or blood vessel problems within the past 3 months, unstable heart rhythm, or unstable chest pain, or any other serious illness or abnormal test result that the study doctor believes would put the person at increased risk
• Women who are pregnant or breastfeeding, or anyone of reproductive age who is unwilling to use effective contraception from screening until 6 months after the last dose
• People who the study doctor believes are unlikely to follow the study's procedures and requirements

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