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 in clinical research, who fully understand the study, and who are able to sign a consent form and complete all required procedures
• People aged 18 to 75 years old (any gender)
• People who have been diagnosed with hepatocellular carcinoma (a type of liver cancer) confirmed by a tissue or cell test, or diagnosed using recognised medical guidelines (AASLD criteria)
• People whose liver cancer has stopped responding to, progressed on, or who could not tolerate at least one standard treatment (such as PD-1/PD-L1-based combination therapy, lenvatinib, or sorafenib)
• People whose liver cancer is classified as Barcelona Clinic Liver Cancer (BCLC) stage C, or BCLC stage B if local treatment is not suitable for them
• People who have at least one measurable area of cancer that can be assessed using standard imaging methods (RECIST v1.1 criteria) within the 4 weeks before starting the trial
• People who are able to provide a tumour tissue sample so that a protein called PD-L1 can be measured (if possible)
• People who have had enough time pass since their last cancer treatment before starting the trial, and whose side effects from previous treatments have largely resolved (confirm with trial site for specific timeframes)
• People whose liver is functioning at a level rated as Child-Pugh grade A within the 7 days before starting the trial
• People with a physical performance score of 0 or 1 on the ECOG scale (a measure of how well a person is able to carry out daily activities) in the week before joining
• People with an expected survival of at least 3 months
• People whose hepatitis B and hepatitis C virus levels meet specific requirements set by the trial (confirm with trial site for details), and who do not have both hepatitis B and hepatitis C active at the same time
• People whose blood tests confirm that their organs are functioning adequately in the 14 days before starting the trial
• People who agree to use at least one highly effective form of contraception during the trial and for at least 6 months after the last dose; women who could become pregnant must have a negative pregnancy test within 7 days before joining

Who may not be able to join:

• People with certain other types of liver or bile duct cancer (such as hepatobiliary duct cell carcinoma, mixed cell carcinoma, or fibroblastic layer cell carcinoma)
• People who have had another cancer diagnosed within the past 2 years, unless it was an early-stage cancer that was fully treated (such as certain skin cancers, early cervical cancer, or early thyroid cancer)
• People who have a history of hepatic encephalopathy (a condition where the liver cannot remove toxins from the blood, affecting the brain), or who have had a liver transplant, or who are being considered for an organ or bone marrow transplant
• People who have had serious bleeding from high blood pressure in the veins around the liver or stomach within the past 6 months, or who are considered at high risk of bleeding
• People whose liver cancer has grown into the main portal vein (the major blood vessel supplying the liver) in a way that blocks blood flow, based on imaging (confirm with trial site for specific details)
• People who still need regular fluid drainage for uncontrolled fluid build-up around the lungs, heart, or abdomen after appropriate treatment
• People who have brain or spinal cord lining metastases (cancer spread to the brain or surrounding tissue) that are causing symptoms, have not been treated, or are getting worse
• People who have had major surgery or certain liver-targeted treatments (such as surgery, radiotherapy, or tumour ablation) within the 4 weeks before joining
• People who have received radiation therapy within the past 4 weeks, or radiation to the abdomen or pelvis within the past 8 weeks (except for radiation to treat bone pain)
• People with current or past lung conditions such as interstitial pneumonia, radiation-related lung damage, or drug-related lung damage that could interfere with monitoring for lung side effects
• People with a known history of severe allergic reactions to monoclonal antibody treatments or to any ingredient in the trial drug
• People who have an active serious infection requiring intravenous antibiotics within the 2 weeks before joining
• People with poorly controlled heart conditions, including certain types of heart failure, unstable chest pain, a recent heart attack or stroke within 6 months, uncontrolled abnormal heart rhythms, or high blood pressure that cannot be controlled with treatment
• People who experienced severe immune-related side effects (grade 3 or higher) during previous immunotherapy treatment
• People with an active or suspected autoimmune disease (a condition where the immune system attacks the body), with some exceptions for thyroid conditions and controlled type 1 diabetes managed with insulin
• People who have taken high-dose steroid tablets or other immune-suppressing medications within the 14 days before starting the trial (with some exceptions, such as steroid creams, inhalers, or short-term use before medical scans)
• People who have received a live or live-attenuated vaccine within the 4 weeks before starting the trial (inactivated flu vaccines are permitted)
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP2D6 or CYP3A inhibitors or inducers) within the 2 weeks before joining
• People with active tuberculosis
• People with HIV infection
• People who are pregnant or breastfeeding
• People whom the trial doctor considers unsuitable for the trial for any other reason

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