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 willing to take part voluntarily, sign a consent form, follow the study requirements, and attend follow-up visits
• People who are at least 18 years old at the time of signing the consent form (any gender)
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) confirmed by tissue sample or medical imaging
• People who have at least one tumour that can be measured on a scan, meeting specific size requirements set out in standard measurement guidelines (confirm with trial site)
• People who have not received any previous systemic (whole-body) treatment for their cancer
• People whose liver cancer falls within a specific staging range known as CNLC Ib to IIIa (confirm with trial site)
• People who have at least one of the following features that raise the risk of cancer returning after surgery: a blood protein marker called AFP above 400ng/ml; a single tumour larger than 5cm; more than 3 tumours, or any tumour larger than 3cm; cancer found in or near major blood vessels
• People who have a physical performance rating (ECOG score) of 0 or 1 within the week before enrolling, meaning they are fully active or have only minor physical limitations
• People whose blood counts and organ functions meet the required health thresholds (confirm with trial site)
• Women who could become pregnant must agree to either avoid heterosexual intercourse or use a highly effective contraceptive method during treatment and for at least 6 months after the last dose

Who may not be able to join:

• People who have already received systemic (whole-body) cancer treatment
• People with a physical performance rating (ECOG score) above 1, meaning significant physical limitations
• People with confirmed cancer that has spread outside the liver
• People who are pregnant (with a positive pregnancy test before starting treatment) or currently breastfeeding
• People with a known allergy or intolerance to the study drug (a type of immunotherapy called a PD-1 monoclonal antibody) or any of its ingredients
• People who have had, or currently have, a serious abnormal opening or leak in the digestive tract or elsewhere in the body (grade 3 or above, as defined by medical grading standards)
• People who have had a major surgical procedure (other than a biopsy) within the 4 weeks before starting the study drug, or whose surgical wound has not fully healed
• People who have had a heart attack or severe/unstable chest pain (angina) within the 6 months before enrolling
• People with poor liver or kidney function, such as jaundice, fluid build-up in the abdomen, or specific abnormal test results for bilirubin or creatinine (confirm with trial site)
• People with an ongoing infection rated as moderate to severe (grade 2 or above)
• People who have had a blood clot, stroke, or mini-stroke (transient ischaemic attack) within the past 6 months
• People with high blood pressure that remains poorly controlled despite medication (systolic above 160mmHg or diastolic above 100mmHg)
• People with an active autoimmune disease, or a history of autoimmune disease in the past two years
• People with active cancer spread to the brain or the lining of the brain or spinal cord
• People who are planning to have, or have previously had, an organ transplant or bone marrow transplant from a donor
• People with a known history of active tuberculosis
• People who have had gastrointestinal (gut) bleeding in the past 6 months, or who are at clear risk of such bleeding
• People with a known history of HIV infection
• People with active hepatitis B or hepatitis C that has not been properly treated; people with hepatitis B must have their viral levels reduced to below a specified threshold before enrolling (confirm with trial site)
• People with substance misuse issues, or any medical, psychological, or social circumstances that could affect their safety or ability to follow the study
• People who still have unresolved side effects (grade 1 or above) from a previous treatment, with the exception of hair loss, anaemia, or low thyroid function
• People with a history of severe lung conditions such as pulmonary fibrosis, interstitial lung disease, or radiation- or drug-related lung damage
• People who have taken a strong CYP3A4 inhibitor medication (a type of drug that affects how other medicines are processed in the body) within the 7 days before joining the study (confirm with trial site)
• People who have another active cancer, or who have had another untreated cancer in the past 5 years — with some exceptions for certain fully treated cancers such as specific skin cancers, carcinoma in situ of the breast or cervix, treated superficial bladder cancer, or treated prostate cancer with normal tumour markers (confirm with trial site)
• People who the research team determines, after a full assessment, are not suitable to participate
• People who are currently taking part in another clinical trial

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