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 aged 18 to 75 years (any gender) and willing to sign a consent form
• People whose liver cancer has been diagnosed using the 2018 American Association for the Study of Liver Diseases (AASLD) guidelines, and whose cancer is considered inoperable or has spread, at certain defined stages (confirm with trial site)
• People who have not previously received any systemic (whole-body) or local treatment for their liver cancer
• People who have at least one tumour that can be measured on a scan, assessed using a standard measurement system called RECIST 1.1
• People whose liver function scores 7 points or fewer on a standard liver health scale called Child-Pugh (confirm with trial site)
• People whose general health and ability to carry out daily activities is rated 0 or 1 on a standard scale called the ECOG performance scale, meaning they are fully active or restricted only in physically strenuous activity
• People whose liver cancer has been confirmed by a tissue or cell sample taken from a tumour
• People who are able to provide a fresh tumour tissue sample large enough for detailed genetic analysis
• People whose heart, liver, and kidney function fall within the acceptable ranges set by the trial, based on blood tests and a heart tracing (ECG) (confirm with trial site for specific values)
• People who agree to use effective contraception from the time of signing the consent form until 6 months after the last dose of the trial medicine — this applies to men who can father children and women who could become pregnant, including those who have been in menopause for fewer than 2 years
• People who are able and willing to follow the study schedule and attend all required follow-up visits

Who may not be able to join:

• People whose liver cancer is described as "diffuse" (spread widely throughout the liver without a distinct tumour)
• People with specific subtypes of liver cancer, including fibrolamellar HCC, cholangiocarcinoma (bile duct cancer), or mixed HCC
• People who have blood clots in certain major blood vessels connected to the liver or abdomen, such as the main portal vein, superior mesenteric vein, or vena cava
• People with a history of disease affecting the lining of the brain and spinal cord, or who have cancer that has spread to the brain or its surrounding tissue
• People with a history of certain lung conditions such as idiopathic pulmonary fibrosis, organising pneumonia, drug-induced pneumonia, or idiopathic pneumonia — or people whose screening chest scan shows signs of active pneumonia
• People who currently have another active cancer, unless it is a cancer that has been fully treated, has been in remission for more than 5 years, or is considered by the trial doctors to be very unlikely to return (such as certain treated skin cancers, thyroid cancers, or pre-cancerous cervical conditions)
• People who have had a bone marrow transplant, an organ transplant from another person, or a stem cell transplant from another person
• People who need to take immunosuppressant medicines regularly — these are medicines that reduce the immune system's activity — including those with severe asthma, autoimmune diseases, or a known immune deficiency condition (some exceptions may apply — confirm with trial site)
• People with an active bacterial or fungal infection confirmed by a doctor, or active tuberculosis, or a past history of tuberculosis
• People who test positive for HIV, syphilis, active hepatitis C, or active hepatitis B
• People with an active herpes virus infection (unless scabs have been present for more than 4 weeks) or a recent respiratory virus infection (unless fully recovered for more than 4 weeks)
• People with uncontrolled medical conditions such as active serious infection, heart failure with symptoms, unstable chest pain (angina), irregular heart rhythm, severe heart or blood vessel disease, or other conditions the trial doctors consider unsuitable
• People with a history of substance abuse, mental illness, or other psychological or social factors that could affect their ability to give informed consent or follow the study requirements
• People with a known history of allergy to food, medicines, or vaccines, or who the trial doctors believe may be allergic to immunotherapy treatments
• Women who are pregnant or currently breastfeeding
• People who the trial doctors believe are not suitable for the trial or are unlikely to be able to complete it for any other reason

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