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 have signed a written consent form before taking part in the trial
• People who have been confirmed to have hepatocellular carcinoma (a type of liver cancer) through a tissue or cell sample, or who meet established medical diagnostic guidelines for this condition
• People whose liver cancer has been staged at a specific advanced level (CNLC Stage IIIa under Chinese liver cancer guidelines), is not suitable for surgery, tumour destruction, or liver transplant, and for whom a specific type of procedure called HAIC (a way of delivering chemotherapy directly to the liver) is considered appropriate by the trial centre
• People whose liver is functioning at a level classified as Child-Pugh A or B (a measure of liver health — confirm with trial site)
• People who have at least one tumour that can be measured using standard imaging criteria
• People who are well enough to carry out light activity and care for themselves, rated 0 or 1 on a standard health and activity scale (ECOG score)
• People whose blood counts, liver function, kidney function, and blood clotting results meet specific minimum levels without having needed a recent blood transfusion or certain medications to boost those levels
• Women who could become pregnant must have a negative pregnancy test within 3 days before the first dose
• People who agree to use highly effective contraception (with less than 1% annual failure rate) throughout treatment and for 120 days after the last dose, if there is any risk of conception

Who may not be able to join:

• People whose liver cancer includes specific rare subtypes such as fibrolamellar, sarcomatoid hepatocellular carcinoma, or cholangiocarcinoma (bile duct cancer)
• People whose liver cancer has previously been treated and has come back (recurrence)
• People with autoimmune hepatitis (a condition where the immune system attacks the liver — confirmed by a liver biopsy)
• People who have a history of hepatic encephalopathy (a brain condition caused by liver failure) or who have had a liver transplant
• People with diffuse liver cancer (cancer that has spread throughout the entire liver)
• People who have fluid build-up in the chest, abdomen, or around the heart that requires drainage
• People with a history of kidney disease or a condition called nephrotic syndrome
• People who have had bleeding from swollen veins in the food pipe or stomach (related to high blood pressure in the liver) in the past 6 months, or who have severely enlarged veins seen on a recent scope procedure, or who are assessed as being at high risk of such bleeding
• People who have had a serious blood clot or blockage in an artery or vein in the past 6 months, such as a heart attack, stroke, blood clot in the lungs, or deep vein clot
• People who have had any life-threatening bleeding event
• People who have been regularly taking aspirin or similar medicines that affect how blood clots before the first dose
• People with high blood pressure that cannot be controlled with medication, or who have a history of hypertensive crisis or related brain complications
• People with significant heart failure symptoms, poorly controlled irregular heartbeat, a specific inherited heart rhythm condition, or an abnormal heart rhythm reading on a screening test
• People who have had bowel perforation, bowel blockage, major bowel surgery, or conditions such as Crohn's disease, ulcerative colitis, or chronic diarrhoea in the past 6 months
• People who have had major surgery (such as on the brain, chest, or abdomen) within 4 weeks before the first dose, or who have wounds, ulcers, or fractures that have not healed; or who have had a tissue biopsy or minor surgery within 7 days before the first dose (other than a standard blood draw or IV line placement)
• People with a history of or current pulmonary fibrosis, interstitial lung disease, or severely reduced lung function
• People with an active hepatitis B or hepatitis C infection
• People with active tuberculosis or who have received tuberculosis treatment within the past year
• People with HIV infection or a syphilis infection that requires treatment
• People with a serious active infection that is not well controlled, or who were hospitalised for a severe infection within the past 4 weeks
• People who have received immune-suppressing medications within 4 weeks before the first dose
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the trial
• People who have received certain traditional Chinese medicines with cancer indications or immune-modifying drugs within 2 weeks before the first dose
• People who have previously received any treatment targeting specific immune checkpoint proteins (such as anti-PD-1, anti-PD-L1, anti-CTLA-4, or similar therapies)
• People with a known allergy to any ingredient in the study drug (Cadonilimab)
• People who have taken part in another clinical trial within 4 weeks before the first dose
• People who are pregnant or breastfeeding
• People whom the trial investigator considers unsuitable for the trial for any other reason

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