Phase 3 Liver Cancer Trial, Recruiting

Written by an AI model from the 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 diagnosed with advanced liver cancer (BCLC Stage C), confirmed either through a tissue sample or by clinical assessment
• People whose liver cancer is suitable for a procedure called TACE (a treatment that delivers chemotherapy directly to the liver through blood vessels)
• People who have not previously received any systemic therapy, TACE, or other liver-directed treatments (such as TARE, TAE, or HAIC), or radiation therapy for their liver cancer
• People whose liver is still functioning reasonably well, classified as Child-Pugh class A (confirm with trial site)
• People with a general health and activity level rated as ECOG 0 or 1, meaning largely able to carry out daily activities (confirm with trial site)
• People with a life expectancy of at least 3 months
• People who have at least one measurable tumour inside the liver
• People whose blood counts and organ function meet the required levels (confirm with trial site)
• People with active Hepatitis B, provided antiviral treatment has reduced the virus to a very low level in the blood
• People with Hepatitis C, provided they have completed anti-hepatitis C treatment

Who may not be able to join:

• People whose liver cancer has grown into the main portal vein or into both its major branches
• People whose cancer has invaded the main vein that carries blood to the heart (vena cava)
• People whose cancer has spread to the brain or central nervous system
• People with a history of a condition called hepatic encephalopathy (brain problems caused by liver failure)
• People who have previously had an organ or cell transplant
• People with uncontrolled fluid build-up in the abdomen, around the lungs, or around the heart
• People who have had bleeding from swollen veins in the oesophagus or stomach within the 6 months before the start of the study
• People found to have severely swollen veins in the oesophagus or stomach on a scope examination within the 3 months before the first dose, or who are assessed by the trial doctor as having a high risk of bleeding related to portal hypertension (including an enlarged spleen seen on scans)
• People who have had any life-threatening bleeding event in the past 3 months, including bleeding that required a blood transfusion, surgery, or ongoing medication
• People who have had a serious blood clot event in the past 6 months, such as a heart attack, unstable chest pain, stroke, mini-stroke, blood clot in the lungs, or deep vein thrombosis
• People who have taken high-dose aspirin (more than 325 mg/day for 10 or more days in a row) or certain blood-thinning medications such as clopidogrel or dipyridamole within 2 weeks before the first dose
• People with high blood pressure that cannot be controlled with medication, or a history of a hypertensive crisis or related brain complications
• People with significant heart failure, poorly controlled irregular heartbeat, a known inherited heart rhythm condition, or a particular heart rhythm measurement (QTc) above 500 ms on screening
• People with serious bleeding disorders or clotting problems, or who are currently receiving clot-dissolving (thrombolytic) therapy
• People with a history of a hole or abnormal opening in the gut (perforation or fistula), bowel blockage requiring intravenous nutrition, extensive bowel removal, Crohn's disease, ulcerative colitis, or chronic diarrhoea within the past 6 months
• People with a history of or current lung conditions such as pulmonary fibrosis, interstitial lung disease, or severely reduced lung function
• People with active tuberculosis (TB), or who have received TB treatment within the past year
• People who are HIV positive or have a known 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 4 weeks before the first dose
• People who have had an active autoimmune disease requiring systemic treatment within the past 2 years (certain replacement therapies such as thyroid hormone or insulin are generally permitted — confirm with trial site)
• People who have received immune-suppressing medications within 4 weeks before the first dose (certain low-dose or locally applied steroids are generally permitted — confirm with trial site)
• People who have had major surgery such as brain, chest, or abdominal surgery within 4 weeks before the first dose, or who have wounds, ulcers, or fractures that have not healed
• People who have received certain traditional Chinese medicines with cancer indications or immune-modulating treatments within 2 weeks before the first dose
• People with a history of another cancer other than liver cancer (HCC)
• People with a known allergy to any of the study drugs (sintilimab, bevacizumab, or lenvatinib) or who have had a severe allergic reaction to similar medications in the past
• People who are pregnant or breastfeeding
• People with serious ongoing physical or mental health conditions, or significant laboratory abnormalities, that the trial doctor considers would make participation unsafe or interfere with the trial results

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