Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from the 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 aged 18 to 80 years, of any gender
• People who are willing to take part voluntarily and are able to sign a consent form themselves, or have a guardian sign on their behalf
• People who have been formally diagnosed with hepatocellular carcinoma (liver cancer) at stage II or III according to the China liver cancer staging system
• People whose liver cancer is not suitable for surgery or local treatments (such as ablation, interventional procedures, or radiation), or whose cancer has come back or gotten worse after surgery and/or local treatment, and who have already tried at least two lines of standard systemic treatment that either stopped working or caused intolerable side effects
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1)
• People who have tumour tissue samples available from within the last two years (as a paraffin block or unstained slides) that show a specific combination of cell markers (CD19/CD68 double positive cells) detected by laboratory testing
• People whose liver function score (Child-Pugh) is 7 or below and who have no history of a condition called hepatic encephalopathy (confusion caused by liver disease)
• People with a general health performance score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physical activity
• People who are expected to survive for at least 12 weeks
• People whose side effects from previous treatments have settled or reduced to a mild level (grade 1 or lower), with some exceptions as determined by the treating doctor

Who may not be able to join:

• People with active cancer that has spread to the brain
• People who have previously received an organ transplant or are currently waiting for one
• People who have had an active autoimmune disease (such as lupus, rheumatoid arthritis, or ulcerative colitis) requiring ongoing immune-suppressing medication within the past two years
• People whose tumour occupies more than 50% of the liver, or who have tumour involvement in major blood vessels near the liver, as assessed by the trial doctors
• People who have received certain treatments within specific timeframes before the cell collection procedure, including: surgery, radiation, or ablation within 4 weeks; major surgery or significant injury within 4 weeks, or planned major surgery during the study; immunotherapy drugs (such as anti-PD-1 or PD-L1 treatments) within 1 week; chemotherapy or targeted therapy drugs (such as sorafenib, regorafenib, or lenvatinib) within 2 weeks; or high-dose corticosteroid medication within 3 days (topical or inhaled steroids are generally allowed)
• People who have had another incurable cancer within the past 5 years or at the same time, except for certain early-stage or non-invasive cancers such as cervical cancer in situ, basal cell skin cancer, or ductal carcinoma in situ of the breast
• People who have previously received any form of cell therapy or gene-modified cell therapy
• People with significant neurological or psychiatric conditions, including epilepsy, stroke, cerebrovascular disease, dementia, Parkinson's disease, severe brain injury, or related disorders
• People with chronic obstructive pulmonary disease (COPD), interstitial lung disease, or clinically significant abnormal lung function test results
• People who, in the assessment of the trial doctors, have large amounts of uncontrollable fluid build-up in the body cavities, such as around the lungs, in the abdomen, or around the heart

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