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 aged 18 to 75 years old at the time of signing the consent form.
• People who have been diagnosed with liver cancer (hepatocellular carcinoma) confirmed by a lab test, where the cancer was able to be fully removed by surgery with clear margins, no spread to blood vessels or bile ducts before surgery, and no more than 3 tumour nodules with no spread outside the liver.
• People whose cancer is considered at high or intermediate risk of coming back after surgery — specifically, those with a single tumour that invaded small blood vessels, those with 2–3 tumours, or those with a single tumour larger than 5 cm that did not invade small blood vessels.
• People who are able to complete at least 4 cycles of standard post-surgery cancer treatment as recommended by clinical guidelines, and whose side effects from any previous cancer treatment have largely resolved.
• People with an expected survival of at least 6 months.
• People who have a general health/activity level score of 0 or 1 on the ECOG scale, meaning they are fully active or have only minor limitations in physically demanding activity.
• People from whom enough tumour tissue can be collected for genetic analysis (confirm with trial site for exact amounts required).
• People whose heart pumping function (left ventricular ejection fraction) is 50% or above on an echocardiogram (heart ultrasound).
• People whose blood test results meet specific thresholds for white blood cells, haemoglobin, platelets, liver function, kidney function, and blood clotting (confirm specific values with trial site).
• Women of childbearing potential who have a negative pregnancy test within 7 days before joining, are not planning a pregnancy in the near term, and are willing to use effective contraception throughout the study.
• Male participants who are willing to use appropriate contraception during the study.
• People who are able to follow the study schedule and attend all required follow-up visits.
• People who are willing to take part voluntarily and sign a consent form.

Who may not be able to join:

• People who have had another cancer requiring active treatment within the past 5 years (some early-stage or low-risk cancers may be exceptions — confirm with trial site).
• People who had major surgery or a significant injury within 2 weeks before the first treatment, or who have wounds or fractures that have not healed.
• People whose tumour genetic analysis does not identify any suitable targets for the personalised immunotherapy used in this trial.
• People who have had, or are planning to have, a bone marrow transplant, organ transplant, or stem cell transplant from a donor.
• People who require medications that suppress the immune system, including steroid treatments above a low daily dose, within 7 days before the first study treatment.
• People who have received any other vaccine within 4 weeks before starting the study, or who are expected to need another vaccine during the study or within 60 days after the last study treatment.
• People with a serious active or uncontrolled infection (including bacterial, fungal, or viral), or active tuberculosis.
• People with certain active viral infections, including hepatitis B, hepatitis C, HIV, or syphilis, based on blood test results (confirm specific thresholds with trial site).
• People with a history of autoimmune disease or immune deficiency that required immune-suppressing treatment (some conditions such as vitiligo, well-managed thyroid conditions, or mild psoriasis may be exceptions — confirm with trial site).
• People with significant heart or brain-related conditions, including recent heart failure, heart attack, stroke, unstable chest pain, certain heart rhythm problems, or poorly controlled high blood pressure, within the period before starting treatment (confirm specific timeframes with trial site).
• People with serious lung conditions such as pulmonary fibrosis, interstitial lung disease, severe asthma, or significantly reduced lung function.
• People with clinically significant fluid build-up in the abdomen, around the lungs, or around the heart that is moderate to severe or uncontrolled.
• People with substance abuse issues, or psychological or social circumstances that may affect their ability to take part in or understand the study.
• People with a known history of serious allergic reactions to immunotherapy treatments or vaccines, or others considered at risk of such a reaction by the treating doctor.
• People assessed by the treating doctor as unsuitable for the trial for any other reason.
• People in vulnerable groups, including those with mental illness, cognitive impairment, critical illness, or who are pregnant or breastfeeding.

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