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 diagnosed with liver cancer (hepatocellular carcinoma/HCC) confirmed either by biopsy or by CT or MRI scan, at a stage where the cancer is either advanced (BCLC stage C) or at an intermediate stage (BCLC stage B) where local treatments are not suitable
• People who have moderate liver scarring (cirrhosis) rated as Child-Pugh B7 or B8
• People whose general health and ability to carry out daily activities is rated as fairly good (ECOG score of 0 or 1, meaning fully active or restricted in strenuous activity only)
• People with a Hepatitis B infection who are receiving effective antiviral treatment and whose virus levels are below 500 IU/mL at the screening stage (people with Hepatitis C do not need antiviral treatment to be considered)
• People whose blood counts and organ function meet minimum levels, including: enough white blood cells, platelets, and red blood cells; liver enzyme levels within an acceptable range; bilirubin below a certain level; blood clotting within an acceptable range; and kidneys functioning well enough (confirm specific thresholds with trial site)
• People who weigh more than 30 kilograms
• People aged 18 years or older
• People who are able and willing to follow all study requirements, including attending all scheduled visits and follow-up appointments
• People who have a life expectancy of at least 12 weeks
• People who have at least one measurable tumour that has not previously been treated with radiation, identifiable on scans according to standard measurement criteria (RECIST 1.1)
• People who are able to provide written informed consent

Who may not be able to join:

• People whose liver cancer could potentially be cured by surgery or other curative treatments
• People who have had uncontrolled episodes of confusion caused by liver disease (hepatic encephalopathy) in the past 6 months (people who are stable on medication for this condition may still be considered)
• People with active substance or alcohol misuse at the time of enrolment that, in the treating doctor's opinion, could affect their safety or ability to follow the study plan
• People who have, or have had, another cancer whose progression or treatment could interfere with the safety or results of this study, in the treating doctor's opinion
• People who have previously received systemic (whole-body) treatment for advanced or metastatic liver cancer
• People who have participated in another clinical trial using an experimental treatment within the past month
• People currently enrolled in another interventional clinical trial (participation in non-interventional or observational studies may be acceptable — confirm with trial site)
• People currently receiving any other cancer treatments, including chemotherapy, biological therapies, or hormonal cancer therapies (hormonal therapy for non-cancer conditions, such as hormone replacement therapy, may be acceptable)
• People who have received radiation therapy covering more than 30% of the bone marrow, or wide-field radiation, within 4 weeks before the first study dose
• People who have had a major surgical procedure within 28 days before the first study dose (minor surgery on isolated lesions for comfort care may be acceptable)
• People who have had an organ transplant from another person
• People with active or previously documented autoimmune or inflammatory conditions, such as inflammatory bowel disease, lupus, rheumatoid arthritis, or similar disorders — though some exceptions apply, including people with vitiligo, hair loss (alopecia), stable thyroid conditions on hormone replacement, certain skin conditions not requiring systemic treatment, celiac disease managed by diet alone, or those with no active disease for at least 5 years (confirm with trial site)
• People with serious uncontrolled illnesses, such as active infections, uncontrolled heart failure, uncontrolled high blood pressure, unstable chest pain, irregular heart rhythms, lung disease, serious ongoing digestive problems, or significant mental health or social situations that could affect safe participation
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis)
• People with a history of a primary immune system deficiency condition
• People who have used immune-suppressing medications within 14 days before the first dose (certain exceptions apply, such as low-dose steroid inhalers, nasal sprays, topical treatments, local injections, or very low-dose oral steroids — confirm with trial site)
• People who have received a live vaccine within 30 days before the first dose (and live vaccines would also not be permitted during treatment or for up to 90 days after the last dose)
• People who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the screening period through to 90 days after the last dose of durvalumab alone, or 180 days after the last dose if durvalumab and tremelimumab were given together
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People who have previously been enrolled in a clinical trial involving durvalumab and/or tremelimumab
• People with a history of another cancer, except those treated with curative intent at least 2 years ago with no known active disease and low risk of return, or certain skin cancers that have been treated with potentially curative therapy

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