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 able to give written agreement to participate, including following all study rules and procedures
• People who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed, confirmed either by tissue sample or by specific liver imaging results showing characteristic patterns in people with liver cirrhosis or chronic hepatitis B
• Adults aged 18 years or older at the time of joining the study
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity but able to do light work)
• People who weigh more than 30 kg
• Women who are post-menopausal (as defined by specific criteria based on age and hormone levels), or women who test negative for pregnancy before starting the study
• People with a life expectancy of at least 12 weeks
• People who are willing and able to attend all scheduled visits and follow all study procedures for the full duration of the study
• People whose liver tumour(s) measure between 5 and 25 cm, with no more than 3 separate tumour spots
• People with certain limited levels of tumour involvement in the portal vein (the major blood vessel to the liver), specifically classified as Vp1, Vp2, or Vp3 (confirm with trial site for details)
• People where the healthy portion of liver volume, after accounting for the tumour, is greater than 700 cc
• People with liver function rated as Child-Pugh class A or B7 (a standard measure of how well the liver is working)
• People who have not previously received immunotherapy treatment
• People with a hepatitis B infection who are already on antiviral medication that has brought the virus to a sufficiently low level, and who are willing to continue that medication throughout the study and for 6 months after finishing study treatment
• People with at least one tumour that can be measured using standard imaging criteria (RECIST v1.1)
• People whose blood counts and organ function meet the following minimum levels (as measured by blood tests): haemoglobin at least 9.0 g/dL; neutrophil count at or above a specified minimum; platelet count at least 75,000 per mm³; bilirubin within 1.5 times the normal upper limit; liver enzymes (AST/ALT) within 2.5 times the normal upper limit (or up to 5 times if liver spread is present); and kidney function (creatinine clearance) above 45 mL/min

Who may not be able to join:

• People who have taken part in another clinical trial using an experimental treatment within the 4 weeks before starting this study
• People currently enrolled in another interventional clinical trial at the same time
• People who still have significant side effects (grade 2 or higher on a standard scale) from previous cancer treatments, with some exceptions such as hair loss or certain stable lab results
• People currently receiving any other chemotherapy, biological therapy, or hormonal cancer treatment (hormonal therapy for non-cancer reasons is acceptable)
• People who have previously had radiation treatment to the liver area, or internal radiation therapy targeting the liver
• People who have had major surgery within 28 days before starting the study
• People with a history of a primary immune system deficiency disorder, or who have received an organ transplant from another person
• People with active or previously documented autoimmune or inflammatory conditions (such as lupus, Crohn's disease, rheumatoid arthritis, and similar conditions), with some exceptions including stable hypothyroidism on medication, vitiligo, hair loss, certain skin conditions not needing systemic treatment, celiac disease controlled by diet, or conditions with no active disease in the last 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 heartbeat, lung disease, severe ongoing diarrhoea, or significant mental health or social situations that would make following the study plan difficult
• People with a history of another cancer, unless it was successfully treated at least 5 years ago with a low risk of return, or was a treated non-melanoma skin cancer or pre-cancerous condition with no current signs of disease
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord
• People with cancer that has spread outside the liver
• People with untreated cancer spread to the brain or its surrounding membranes
• People with an active infection including tuberculosis, active hepatitis B (unless meeting specific criteria above), active hepatitis C (unless a specific virus test is negative), or HIV
• People who have used immune-suppressing medications within 14 days before starting the study drugs, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions
• People who have received a live vaccine within 30 days before starting the study
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the screening period until 90 days (or 180 days for combination therapy) after the last dose of study treatment
• 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 study involving the specific study drugs (durvalumab and/or tremelimumab)
• People who have previously received certain types of immunotherapy drugs and experienced serious side effects, had side effects that led to permanently stopping that treatment, or currently require higher-dose immune-suppressing medication as a result
• People whose tumours do not meet the technical requirements for the radiation treatment used in this trial — for example, a single tumour larger than 25 cm, total tumour size exceeding 30 cm, more than 3 separate liver tumour spots, or tumours growing into nearby digestive organs or major bile ducts
• People with tumour involvement in the main portal vein, the opposite branch of the portal vein (Vp4), or the large vein running from the abdomen to the heart (inferior vena cava)
• People with significant fluid build-up in the abdomen that requires drainage procedures or increased medication to manage
• People with hepatic encephalopathy (a condition where the liver is unable to remove toxins, affecting brain function)
• People with a current or past history of bleeding from varicose veins in the digestive tract

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