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:

• Adults between 18 and 75 years old, of any gender
• People diagnosed with primary liver cancer (hepatocellular carcinoma) either through standard clinical diagnosis guidelines or confirmed by a tissue or cell sample, with at least one measurable tumour
• People who have not had any previous whole-body (systemic) cancer treatment, whose tumour cannot be surgically removed or treated with a curative procedure, but who are well enough to tolerate a procedure called TACE (a treatment delivered through the blood vessels to the liver)
• People whose liver cancer is at a specific stage known as CNLC Stage IIa through IIIb
• People whose liver is functioning at a level classified as Child-Pugh Grade A, or Grade B with a score of 5–7 points (confirm with trial site)
• People with a general health and activity level scored at 0 or 1 on a standard medical scale (meaning largely able to carry out daily activities)
• People with an expected survival of at least 12 weeks
• People with an active hepatitis B infection whose virus levels are below a certain threshold and who have been on hepatitis B antiviral treatment for at least 14 days before starting the trial, and are willing to continue that treatment throughout; people with hepatitis C must be receiving antiviral treatment as per local guidelines and have only mildly elevated liver function results
• People whose blood counts and organ function test results meet specific minimum levels, including haemoglobin, white blood cells, neutrophils, platelets, liver enzymes, bilirubin, and kidney function (confirm exact values with trial site)
• Women of childbearing age who have a negative pregnancy test within 7 days before joining and agree to use appropriate contraception during the trial and for 24 weeks after the last dose; men who agree to use appropriate contraception or have had surgical sterilisation during the trial and for 24 weeks after the last dose
• People who agree to participate voluntarily and are willing and able to attend all required follow-up visits

Who may not be able to join:

• Women who are pregnant or breastfeeding
• People whose cancer has been confirmed by pathology to be bile duct cancer (cholangiocarcinoma) or a mixed cell type
• People with a diffuse (widespread throughout the liver) form of liver cancer
• People with autoimmune diseases, who have had an organ or stem cell transplant, or who have or have had another cancer (except for certain cured skin cancers or early-stage cervical cancer)
• People with significant confusion, mental illness, or any condition that would prevent them from cooperating with treatment
• People who have taken part in another clinical trial within the past three months
• People who have previously had another cancer diagnosis, or have previously received targeted therapy or treatments that work on the immune system in a specific way (PD-1 or PD-L1 inhibitors)
• People who have had major surgery, chemotherapy, or other treatments directed at the tumour (such as radiation or ablation) within one month before joining the trial
• People who have taken immune-suppressing medications or high-dose steroid medications within 14 days before joining (above a specified dose threshold)
• People whose liver function is classified as Child-Pugh Grade C and cannot be improved with supportive liver treatment
• People who have had a bleeding episode from varicose veins in the oesophagus or stomach within one month before starting treatment
• People with uncorrectable blood clotting problems or severe blood abnormalities causing a high risk of serious bleeding, or a very low platelet count
• People with persistent, difficult-to-manage fluid build-up in the abdomen, around the lungs, or related to cancer
• People with an active infection, particularly involving the bile duct system
• People with severe failure of major organs including the liver, kidneys, heart, lungs, or brain
• People who have previously had an allergic reaction to PD-1 or PD-L1 medications or any of their components, or to similar treatments used in other trials
• People with high blood pressure that cannot be adequately controlled with medication (above 140 mmHg systolic or 90 mmHg diastolic)
• People with a history of serious heart conditions, including heart attack, poorly controlled irregular heartbeat, significant heart function impairment, or a heart pumping function below 50% on ultrasound
• People with a significant level of protein detected in their urine
• People who are unable to swallow tablets, or who have a condition that significantly affects the body's ability to absorb medication through the digestive system
• People with other existing health conditions that, in the opinion of the investigating doctor, would place them at serious risk or prevent them from completing the study
• People for whom radiation therapy, targeted therapy, or immunotherapy is medically unsuitable (contraindicated)

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