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 19 years or older who are able to give written consent to participate and follow the study requirements
• People who have been diagnosed with liver cancer (hepatocellular carcinoma, or HCC), confirmed either by a tissue sample (biopsy) or by medical imaging scans according to recognised guidelines
• People whose liver cancer is classified as intermediate stage (BCLC B) or advanced stage (BCLC C), with or without a small amount of cancer that has spread to one other organ (no more than 5 spots in that organ)
• People who have at least one area of liver cancer that has never been treated with local procedures such as chemoembolisation, ablation, or alcohol injection
• People whose liver is functioning at a level called Child-Pugh class A (a score of 5 or 6), indicating relatively preserved liver function
• People with a general health and activity level rated 0 or 1 on the ECOG scale, meaning they are fully active or have minor restrictions but are able to carry out light work
• People with a life expectancy of at least 12 weeks, as assessed by the treating doctor
• People who weigh more than 30 kg
• People whose blood counts, liver function, and kidney function meet the specific levels required by the trial (confirm with trial site for exact values)
• Women who are past menopause, or women who are pre-menopausal and have a negative pregnancy test and agree to use two forms of contraception during the study
• Men who are either surgically sterile, or who agree to use an acceptable form of contraception during the study if their partner could become pregnant
• People who are willing and able to attend all required visits and follow the study schedule for its full duration

Who may not be able to join:

• People whose liver cancer may be treatable with surgery, radiofrequency ablation, or immediate liver transplant
• People who have previously been treated with certain types of immunotherapy drugs (including anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 treatments), or who have previously taken part in a clinical trial involving durvalumab or tremelimumab
• People who have had an organ transplant or bone marrow/stem cell transplant
• People who currently have, or have recently had, another type of cancer — with some exceptions such as certain skin cancers, early cervical cancer, papillary thyroid cancer, early stomach cancer, or other cancers from which the person has been cancer-free for at least five years
• People who have had a severe allergic reaction (such as anaphylaxis) to contrast dye used in scans, if that reaction cannot be managed with pre-treatment medication
• People who have participated in another clinical trial involving an investigational drug within the past 8 weeks (or longer, depending on the drug), or who are currently enrolled in another interventional clinical trial
• People who have received cancer treatment (such as chemotherapy, immunotherapy, or targeted therapy) too recently before the trial start date (confirm with trial site for the exact timeframe required)
• People who still have unresolved side effects of grade 2 or higher from previous cancer treatments (with some exceptions such as hair loss or skin colour changes)
• People who are currently receiving any other cancer treatment at the same time
• People who have had radiation therapy to the liver, or total body irradiation, for any reason
• People who have had major surgery within 28 days before the trial start
• People with active or previously documented autoimmune or inflammatory conditions (such as Crohn's disease, lupus, rheumatoid arthritis, or similar conditions) — though some exceptions apply, such as stable thyroid conditions on hormone replacement, vitiligo, or conditions not requiring systemic treatment (confirm with trial site)
• People with serious uncontrolled illnesses, such as active infections, uncontrolled high blood pressure, unstable heart conditions, certain lung conditions, serious bowel conditions with diarrhoea, or mental health conditions that could affect participation
• People with a history of cancer spreading to the membranes surrounding the brain and spinal cord (leptomeningeal carcinomatosis)
• People with a known primary immune deficiency condition, or who have tested positive for HIV
• People with an active infection such as tuberculosis (note: people with chronic hepatitis B or C may be eligible under certain conditions — confirm with trial site)
• People who have used immunosuppressive medications within 14 days before the trial start, with some exceptions such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions during scans
• People who have received a live vaccine within 30 days before the trial start
• Women who are pregnant or breastfeeding, or people of reproductive potential who are not willing to use effective contraception from the screening period until at least 90 days after the last dose of durvalumab or tremelimumab, or 180 days after the last chemoembolisation procedure
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People whom the trial investigator considers unsuitable to participate or unlikely to be able to follow the study requirements

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