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 18 or older who have signed a consent form agreeing to take part
• People whose liver cancer (HCC) has been confirmed by a tissue sample (biopsy) examined in a lab
• People whose liver cancer is considered removable by surgery with the goal of removing all of the cancer, in the opinion of their surgical and medical team
• People whose liver cancer is considered high-risk for coming back, because of multiple tumours, a tumour larger than 5 cm, a specific protein marker (AFP) in the blood at 400 ng/mL or above, poorly formed cancer cells, or tiny blood vessel involvement (a scoring tool may be used for tumours between 3–5 cm to assess this risk)
• People who have at least one tumour that can be measured on a scan, according to standard measurement guidelines
• People who are fully active and able to carry out daily activities without restriction (a medical scoring system called ECOG Performance Status of 0 is used to assess this)
• People whose liver is functioning well, as measured by a standard liver scoring system called Child-Pugh Class A
• People with no signs of significant raised pressure in the liver's blood supply (portal hypertension), or only minor raised pressure, if they are being considered for removal of fewer than three liver segments (confirm with trial site)
• People willing to have a tumour tissue sample (biopsy) taken at the start of the study; at least two needle biopsies are needed, or a recent archived sample from within the last 3 months may be accepted if a new biopsy is not possible
• People who have not previously received any treatment for their liver cancer, including local treatments to the liver or systemic (whole-body) treatments
• People whose blood counts and organ function meet specific laboratory thresholds, including white blood cells, platelets, haemoglobin, liver enzymes, kidney function, and blood clotting measures (the trial site will check these)
• People with hepatitis B virus (HBV) infection whose virus levels are low (below 500 IU/mL at screening), who have been on anti-HBV medication for at least 14 days before starting treatment, and who are willing to continue that medication during the study
• People with hepatitis C virus (HCV) infection, whether resolved or ongoing, are eligible
• People who test negative for HIV at screening, or people who test positive but are stable on HIV treatment, have a CD4 count of at least 200/mL, and have an undetectable viral load
• Women who could become pregnant who agree to use contraception or remain abstinent during the study
• Men who agree to use contraception or remain abstinent during the study, and who agree not to donate sperm

Who may not be able to join:

• People whose cancer has spread outside the liver or into major blood vessels
• People with rare or mixed types of liver cancer, such as fibrolamellar HCC, sarcomatoid HCC, or mixed liver-bile duct cancer
• People who have had a significant episode of confusion caused by liver failure (hepatic encephalopathy) within the past year
• People with significantly raised pressure in the liver's blood supply (portal hypertension) who would need removal of more than three liver segments
• People with moderate or severe fluid build-up in the abdomen (ascites)
• People with an active simultaneous infection of both hepatitis B and hepatitis C
• People with an active simultaneous infection of both hepatitis B and hepatitis D
• People who have previously been treated with certain immune-based cancer therapies (immune checkpoint inhibitors, including anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies)
• People who have received any experimental treatment within 28 days before screening
• People who have untreated or incompletely treated swollen veins in the food pipe or stomach (varices) that are bleeding or at high risk of bleeding (an internal camera examination of the upper digestive tract must have been done, and any varices treated, before joining)
• People who have had a bleeding episode from food pipe or stomach varices within the past 6 months
• People with poorly controlled high blood pressure (above 150/100 mmHg on average across multiple readings), though blood pressure medication to bring it within range is permitted
• People with a history of a severe high blood pressure crisis or high blood pressure-related brain swelling
• People with serious blood vessel disease, such as a large aortic aneurysm or recent blood clot in an artery, within the past 6 months
• People who have coughed up significant amounts of blood (2.5 mL or more per episode) within the past month
• People with a known tendency to bleed abnormally or significant clotting problems (not caused by blood-thinning medication)
• People currently using high-dose aspirin (above 325 mg per day) or certain blood-thinning medications such as clopidogrel within the past 10 days (low-dose aspirin below 325 mg per day for heart protection is allowed)
• People currently using full-dose blood-thinning or clot-dissolving medications for treatment purposes within the past 10 days (low-dose preventive blood thinners may be allowed in some cases — confirm with trial site)
• People with a history of abnormal connections between abdominal organs, bowel perforation, or infection inside the abdomen within the past 6 months
• People with a history of bowel blockage or current symptoms of bowel obstruction, or those who need ongoing intravenous fluids, tube feeding, or intravenous nutrition
• People with unexplained free air inside the abdomen (not explained by a recent procedure or surgery)
• People with serious wounds, ulcers, or bone fractures that have not healed
• People with significant amounts of protein in their urine (Grade 2 or above), confirmed by a 24-hour urine test (or equivalent)
• People with a history of inflammatory conditions inside the abdomen within the past 6 months, such as stomach ulcers, diverticulitis, or colitis
• People who have had major surgery, an open biopsy, or a significant injury within the past 28 days, or abdominal surgery or significant abdominal injury within the past 60 days, or who have not yet fully recovered from such a procedure
• People who have not fully healed from minor surgery (such as a tooth extraction) at least 7 days before screening
• People taking anti-inflammatory pain medications (NSAIDs) every day on a regular basis (occasional use for headaches or fever is allowed)
• People who have had a serious infection requiring antibiotics or hospitalisation within the past 4 weeks
• People with any other serious medical condition or abnormal lab results that the trial team considers would make participation unsafe
• People with a history of another cancer within the past 5 years, with some exceptions for certain low-risk or well-treated cancers (confirm with trial site for specific details)
• People with an active or past autoimmune disease or immune deficiency condition, with some exceptions (for example, people with well-controlled thyroid condition on hormone replacement, well-controlled Type 1 diabetes on insulin, or certain mild skin conditions may still be eligible — confirm with trial site)
• People who are pregnant, breastfeeding, or planning to become pregnant during the study (a pregnancy test will be required at screening for women who could become pregnant)
• People whose heart pumping function (left ventricular ejection fraction) is below 50%, as measured by a heart scan within the past 6 months
• People with a history of severe allergic reactions to certain types of laboratory-made antibody treatments
• People with a history of certain lung conditions causing scarring or inflammation, or who have signs of active lung inflammation on a chest scan at screening
• People who have previously had a bone marrow or organ transplant from another person
• People with active tuberculosis

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