Phase 3 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:

• Adults aged 18 or older
• People diagnosed with hepatocellular carcinoma (a type of liver cancer), confirmed either by a tissue sample (biopsy) or by imaging scans using accepted medical guidelines
• People with a high level of tumour spread in the liver, meaning at least one of: a major blood vessel near the liver (the portal vein) is heavily affected by tumour, or a slightly less severe blood vessel involvement combined with tumours in both sides of the liver, or more than half of the liver is affected by tumour. Spread of cancer outside the liver is also permitted.
• People whose liver is still functioning reasonably well, as measured by a standard scoring system called Child-Pugh A
• People who are generally well enough to carry out light activity, rated 0 or 1 on a standard fitness scale used in cancer care (ECOG scale)
• People with a life expectancy of at least 12 weeks
• People weighing more than 30 kg
• People who have at least one tumour that has not been previously treated with radiation and can be measured on scans, with scans taken within 28 days before joining the trial
• People whose blood test results show the body's organs (including kidneys, liver, and bone marrow) are working at an adequate level, across specific measurements including red blood cells, platelets, white blood cells, liver enzymes, bilirubin, kidney function, and blood clotting (confirm specific values with the trial site)
• Women who could become pregnant must be willing to use a highly effective form of contraception throughout the study and for at least 90 days after the last dose of study treatment, and must have a negative pregnancy test within 7 days of starting treatment
• Men who have not been confirmed as infertile must be willing to use a highly effective form of contraception throughout the study and for at least 90 days after the last dose of study treatment
• All participants must agree not to donate or store eggs or sperm during treatment and for 180 days after treatment ends
• People who are able and willing to follow the study schedule, including attending all visits and examinations
• People who have signed a written consent form before any study procedures begin (if someone is physically unable to sign, a trusted person of their choice may confirm consent in writing)
• People who are enrolled in a social security scheme (this appears to be a French regulatory requirement — confirm with the trial site)

Who may not be able to join:

• People who have previously received systemic treatment for this cancer, including immunotherapy, anti-angiogenic therapy, chemotherapy, or any combination of these
• People who have previously received chemotherapy delivered directly into the liver's blood supply (hepatic arterial infusion)
• People diagnosed with specific rare subtypes of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or a mixed liver-and-bile-duct cancer
• People who have experienced confusion or brain problems caused by liver failure (hepatic encephalopathy) in the past 6 months, or who need medications to prevent this condition
• People who have had active bleeding in the digestive tract (such as from swollen veins in the oesophagus or a stomach ulcer) within the past 6 months (additional endoscopy requirements may apply for those with a history beyond 6 months — confirm with the trial site)
• People with ongoing side effects rated moderate or severe (grade 2 or higher) from a previous cancer treatment, with some exceptions such as hair loss or skin pigment changes (certain cases may be reviewed individually — confirm with the trial site)
• People currently receiving any other chemotherapy, biological therapy, or hormonal cancer treatment (hormonal therapy for non-cancer conditions is acceptable)
• People with active or previously documented autoimmune or inflammatory conditions such as inflammatory bowel disease, lupus, rheumatoid arthritis, sarcoidosis, or similar disorders — with some exceptions for stable or mild conditions (confirm with the trial site)
• People with a history of inflammatory lung disease, lung scarring (pulmonary fibrosis), or other serious uncontrolled lung conditions
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord
• People with a currently active hepatitis infection, or certain positive hepatitis B or C markers on blood tests (some people with past, resolved hepatitis infections may still be eligible — confirm with the trial site)
• People known to be HIV positive or to have active tuberculosis
• People with other serious uncontrolled illnesses, such as active infection, uncontrolled high blood pressure, unstable heart conditions, irregular heart rhythm, or ongoing severe diarrhoea
• People with a specific type of irregular heart electrical activity (prolonged QTcF interval of 470 ms or more) detected on a heart tracing (ECG)
• People who have taken immune-suppressing medications within 14 days before starting study treatment, with some exceptions for low-dose or locally applied steroids (confirm with the trial site)
• People who have received a live vaccine within 30 days before starting study treatment
• People who have had an organ transplant from another person, or who are planning to have one
• People who have had a major surgical procedure within 28 days before starting study treatment
• People with another active cancer diagnosed within the past 5 years, with some exceptions for certain easily treated skin cancers, superficial bladder cancer, or early-stage cancers that have been fully treated (confirm with trial site)
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• Women who are pregnant or breastfeeding
• People who have taken part in another treatment trial within 30 days before joining this study
• People who have previously been enrolled in a clinical trial involving the study drugs durvalumab or tremelimumab
• People currently enrolled in another interventional clinical trial (participation in non-interventional or observational studies is acceptable)
• People who are in legal custody or under guardianship
• People who, for geographic, social, psychological, or psychiatric reasons, would be unable to follow the study requirements

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