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:

• Adults aged 18 or older at the time of signing the consent form.
• People diagnosed with liver cancer (hepatocellular carcinoma, or HCC) that has grown beyond certain size/spread limits (called UCSF criteria), confirmed by tissue sample, imaging, or standard clinical assessment, with a life expectancy of at least 12 months.
• People who have had a liver tissue sample (biopsy) taken within the past 3 months, or who are able to have one taken during the screening process.
• People whose general physical functioning has been assessed within the past 7 days and falls within an acceptable range on a standard medical scale (ECOG score of 2 or lower) (confirm with trial site).
• People whose liver function falls within an acceptable range on a standard scoring system (Child-Pugh A or B7, meaning a score of 5 to 7 points) at screening and within 7 days before starting treatment.
• People whose liver cancer can be measured on imaging (at least one tumour spot of 10mm or larger), is not suitable for surgical removal, and has been confirmed on imaging taken within the past 3 months.
• People of childbearing potential who return a negative pregnancy test at screening and agree to use adequate contraception or abstain from sexual activity from screening until 3 months after the last dose of the study drug (Durvalumab).
• People who are willing and able to give written consent and follow the study requirements.

Who may not be able to join:

• People with certain rare or mixed types of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, other rare HCC variants, or a combined liver and bile duct cancer.
• People whose cancer has spread to organs outside the liver.
• People who have a specific type of blood clot blocking major blood vessels connected to the liver (portal vein tumour thrombus VP3-4) or any active tumour clot in the liver veins at screening.
• People who have previously been treated with certain immune therapies (including anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments).
• People who are pregnant, breastfeeding, or planning to become pregnant or to father a child during the study period.
• People with an active or past history of certain autoimmune conditions, including but not limited to lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, or similar conditions.
• People who have little interest in or do not have adequate personal support for the possibility of an organ transplant.
• People who have another cancer that is currently active or being treated, have not fully recovered from previous cancer treatment, or have a significant cancer history that the study doctor considers a reason to exclude them.
• People with a history of certain serious lung conditions, including lung scarring (pulmonary fibrosis), a type of lung inflammation called organising pneumonia, medication-caused lung inflammation, or signs of active lung inflammation seen on a recent chest scan.
• People with active tuberculosis (TB), confirmed by a skin or blood test and a chest X-ray taken within the past 3 months.
• People who are currently infected with both hepatitis B and hepatitis C at the same time.
• People who have had a serious infection in the 4 weeks before starting treatment, such as one requiring hospitalisation, a bloodstream infection, or severe pneumonia, or any active infection the study doctor believes could affect safety.
• People who have received another experimental treatment within 28 days before starting the study treatment.
• People who have received medications that stimulate the immune system (such as interferon or IL-2) within 4 weeks or within 5 times the drug's clearance time (whichever is longer) before starting treatment.
• People who have taken immune-suppressing medications (such as steroids, methotrexate, or similar drugs) within 2 weeks before starting treatment, or who are expected to need them during the study — with some exceptions for short-term or low-dose use for specific medical reasons (confirm with trial site).
• People who have received a live vaccine within 4 weeks before starting treatment, who expect to need one during the study, or who would need one within 5 months after the final dose of the immune therapy.
• People who have had radiation therapy within 28 days, or radiation to the abdomen or pelvis within 60 days, before starting treatment.
• People who have had major surgery, an open biopsy, or a significant injury within 28 days before starting treatment, or abdominal surgery or significant abdominal injury within 60 days, or who have not fully recovered from such a procedure, or who are expected to need major surgery during the study.
• People with any other medical condition, laboratory result, or physical finding that the study doctor believes could make the study drugs unsafe, affect the reliability of the results, or place the person at high risk of complications.

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