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 given written consent before any study procedures begin
• People aged 18 to 75 years, of any gender
• People who have been diagnosed with hepatocellular carcinoma (a type of primary liver cancer), either through clinical assessment or confirmed by tissue or cell testing, according to 2024 Chinese guidelines
• People who have not received any previous treatment for their liver cancer
• People whose liver cancer cannot be surgically removed and is at an advanced or locally advanced stage (classified as CNLC Stage IIa to IIIb)
• People whose doctors estimate they have a life expectancy of more than 6 months
• People who are largely able to carry out daily activities with little or no limitation (rated 0 or 1 on a standard performance scale)
• People whose liver function is rated as Class A or B on the Child-Pugh scoring system
• People whose blood test results show the body's organs are functioning adequately, including: sufficient white blood cell counts without recent growth factor support; sufficient platelet counts without recent transfusion; sufficient red blood cell levels without recent transfusion or medication support; liver enzyme and bilirubin levels within acceptable ranges; kidney function within acceptable limits; blood clotting within acceptable limits; thyroid hormone levels within normal range or near-normal (confirm with trial site); and heart enzyme levels within normal range
• Women of childbearing potential who have a negative pregnancy test within 3 days before starting the study drug, and who agree to use effective contraception during the study and for 8 weeks after the last dose
• All people capable of having children who agree to use highly effective contraception throughout treatment and for 120 days after the last dose of immunotherapy or 180 days after the last dose of chemotherapy, whichever is longer

Who may not be able to join:

• People with certain rare subtypes of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma
• People whose liver cancer has come back after a previous time of being cancer-free
• People who have had a clinical diagnosis of confusion or brain impairment caused by liver disease (hepatic encephalopathy) within the past 6 months
• People with autoimmune hepatitis (a condition where the immune system attacks the liver), confirmed by liver biopsy
• People who have had an organ transplant at any time, or who have any history of liver-related brain impairment
• People whose liver cancer is classified as diffuse (spread throughout the liver in a widespread pattern)
• People who have fluid build-up in the chest, abdomen, or around the heart that requires draining
• People with any history of kidney disease or a condition called nephrotic syndrome
• People who have had bleeding from enlarged veins in the food pipe or stomach (caused by high blood pressure in the liver's blood supply) within the past 6 months; or who have severe variceal disease seen on internal examination within 3 months; or who show signs of high liver blood pressure with a high risk of bleeding as judged by the doctor
• People who have had a serious blood clot or blockage in an artery or vein within the past 6 months, including heart attack, unstable chest pain, stroke, mini-stroke, blood clot in the lungs, or deep vein clot (certain minor or stable clots may be considered separately — confirm with trial site)
• People with serious bleeding disorders, poor blood clotting, or who are currently receiving clot-dissolving treatments
• People currently taking blood-thinning medications such as warfarin (note: certain low-dose preventive blood thinners such as low-molecular-weight heparin may be permitted — confirm with trial site)
• People who regularly use anti-platelet medications such as aspirin, clopidogrel, or similar drugs
• People with high blood pressure that cannot be controlled with medication (above 140/90 mmHg), or who have a history of hypertensive crisis or hypertension-related brain complications
• People with significant heart failure causing symptoms, poorly controlled irregular heartbeat, a condition called long QT syndrome, or a specific heart rhythm measurement above 500 ms on screening
• People who have had a hole or abnormal connection in the digestive tract within the past 6 months, or a history of bowel blockage, major bowel removal, Crohn's disease, ulcerative colitis, or ongoing chronic diarrhoea
• People who have had major surgery to the head, chest, or abdomen within 4 weeks before starting the study, or who have wounds, sores, or fractures that have not healed; also people who have had a needle biopsy or minor procedure within 7 days before starting (except for placement of an intravenous line)
• People with a history of lung scarring, lung inflammation, dust-related lung disease, drug-related lung damage, or severe lung problems
• People with active hepatitis B or C infection above specified levels, or co-infection with both hepatitis B and C markers
• People with active tuberculosis, currently receiving TB treatment, or who have received TB treatment within the past year
• People with HIV infection or active syphilis
• People with a serious active infection that is difficult to control, or who have been hospitalised for a severe infection (such as blood poisoning or severe pneumonia) within the past 4 weeks
• People who have an active autoimmune condition (where the immune system attacks the body) that has required systemic medical treatment within the past 2 years (certain replacement therapies such as thyroid or insulin treatment may be permitted — confirm with trial site); or people with a history of a primary immune system deficiency
• People who have received systemic immune-suppressing medications within 4 weeks before starting the study (certain low-dose or locally applied steroids may be permitted — confirm with trial site)
• People who have received a live vaccine within 4 weeks before starting the study, or who plan to receive one during the study
• People who have used traditional Chinese herbal medicines with anti-cancer properties, or immune-stimulating agents such as thymosin, interferon, or interleukin, within 2 weeks before starting the study
• People with uncontrolled or permanent metabolic disorders, serious non-cancer organ disease, or other conditions that may increase risk or make it difficult to assess outcomes
• People who have been diagnosed with another cancer within the past 5 years (certain fully treated skin cancers or pre-cancerous conditions may be considered separately — confirm with trial site)
• People who have previously been treated with certain types of immunotherapy drugs that act on the immune system's checkpoint pathways (such as anti-PD-1, anti-PD-L1/L2, or anti-CTLA-4 medications)
• People with a known serious allergy to the study drugs (sintilimab, bevacizumab, or ipilimumab N01) or their ingredients, or who have had a severe allergic reaction to other similar antibody-based medicines
• People who have participated in another interventional clinical trial within 4 weeks before starting this study
• Women who are pregnant or breastfeeding
• People with any other medical condition, mental health condition, or abnormal test result that, in the treating doctor's judgement, would make participation unsafe or interfere with the study results

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