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 with advanced liver cancer (hepatocellular carcinoma, or HCC) that cannot be treated with surgery or local treatments, and whose cancer has continued to grow or who could not tolerate one or two previous lines of cancer treatment, and who have either a tissue/cell-based diagnosis of HCC or a clinical diagnosis made according to official Chinese medical guidelines.
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST 1.1 and mRECIST).
• People whose tumour tissue has been tested for a specific set of proteins (Nectin4, NKG2DL, TROP2, B7H3, GPC3, and FAP) using a laboratory method called immunohistochemistry, and where at least two of the first five proteins show positive results (meaning more than 10% of tumour cells carry that marker).
• People whose own T cells (a type of immune cell) meet certain quality standards in pre-trial laboratory testing — specifically, the cells must multiply at least 5 times within 3 days and show at least 10% efficiency when a viral delivery method is used.
• People with a general health/activity score (ECOG performance status) of 0, 1, or 2, meaning they are able to carry out at least some daily activities.
• People with a liver function score (Child-Pugh score) of 6 or below, indicating reasonably preserved liver function.
• People with an expected survival of at least 3 months.
• People who have no medical reasons preventing collection of white blood cells (PBMCs) from their blood.
• People whose blood test results in the 7 days before starting the study drug fall within acceptable ranges for blood counts, liver enzymes, kidney function, clotting ability, heart function, lung function, and blood oxygen levels (confirm specific values with the trial site).
• Women of childbearing age whose pregnancy test is negative within 7 days before starting the study drug, and who — along with fertile male participants — agree to use highly effective contraception throughout the trial and for 12 months after treatment ends.
• People who voluntarily agree to take part, sign an informed consent form, and are willing to follow the trial schedule and attend follow-up appointments.

Who may not be able to join:

• People with an active, uncontrolled infection (hepatitis B or C infections are not automatically excluded — confirm with trial site).
• People with active brain or central nervous system disease, or known cancer spread to the brain causing significant neurological or psychiatric symptoms (as assessed by a standard cognitive test called the MMSE).
• People with known allergies to two or more unrelated foods or drugs, or a known allergy to the pre-treatment chemotherapy drugs used in this trial (such as cyclophosphamide or fludarabine).
• People who still have side effects from previous cancer treatments that have not reduced to a mild level (Grade 1 or below, according to a standard side-effect scale called CTCAE version 5.0) before the pre-treatment chemotherapy begins.
• People who have taken part in another clinical drug or therapy trial within the 4 weeks before the first dose of the study treatment.
• People who have had major surgery within 4 weeks before the first dose and have not fully recovered, or who have had a live vaccine or radiotherapy within 2 weeks before the first dose.
• People who are currently taking high-dose steroid medications (more than 10 mg per day of prednisone or an equivalent) to suppress the immune system, and who have continued this within 2 weeks before starting treatment.
• People who are pregnant or breastfeeding.
• People who have had another type of cancer in the past 5 years, except for certain fully cured skin cancers (basal cell or squamous cell carcinoma), early-stage prostate cancer, or cervical carcinoma in situ.
• People with active inflammatory bowel disease or active ulcers in the digestive tract.
• People who test positive for HIV or syphilis (treponema pallidum).
• People with a large build-up of fluid in the chest or abdomen that is causing symptoms and requires treatment.
• People with a history of active lung disease (such as pneumonia, chronic obstructive pulmonary disease, or asthma) or active tuberculosis of the lungs.
• People with blood system diseases such as leukaemia, lymphoma, myelodysplastic syndrome, or myeloma.
• People with immune deficiency conditions or autoimmune diseases, except for vitiligo (a skin pigmentation condition) (confirm with trial site).
• People who have had significant bleeding in the 3 months before enrolling — for example, coughing up 2.5 mL or more of blood per day, gastrointestinal bleeding, bleeding from oesophageal varices, bleeding stomach ulcers, or vasculitis. People with a positive stool blood test at the start of the trial may need a follow-up gastroscopy; those found to have severe oesophageal or stomach varices on gastroscopy would not be eligible (confirm with trial site).
• People with other serious, poorly controlled health conditions, including uncontrolled high blood pressure (persistently above 150/90 mmHg), poorly controlled diabetes, severe heart failure or heart block, or certain serious heart or blood vessel events (such as heart attack, stroke, blood clots, or coronary procedures) that occurred within the 6 months before the first dose.
• People with a known significant genetic disorder.
• People who have previously had a stem cell transplant or an organ transplant.
• People with a history of substance abuse involving psychotropic drugs that cannot be stopped, or a history of a mental health disorder.
• People with other serious medical conditions or abnormal test results that the trial doctor judges could increase the risks of participation or affect the reliability of the trial results.
• People who the trial doctor believes are unlikely to follow the trial requirements or who have other reasons that make participation unsuitable.

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