Phase 4 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 and are able to follow the study schedule and requirements
• People with a newly diagnosed liver cancer (hepatocellular carcinoma, or HCC) that has been confirmed by a tissue sample (biopsy)
• People who can provide a suitable tumour tissue sample for testing, either from a stored sample or a new biopsy taken during the screening process
• People whose liver cancer falls into one of three size/spread categories: (1) within standard transplant size limits but with a blood protein level (AFP) of 400 ng/mL or higher; (2) slightly larger tumours meeting specific size and number rules; or (3) tumours exceeding those size rules but still confined to the liver, with no spread to blood vessels or other organs, and a liver function score of Child-Pugh A or B7 without fluid build-up (ascites)
• People whose cancer can be measured or assessed using standard imaging criteria (RECIST v1.1)
• People who meet the trial site's urine protein testing standards
• People whose liver cancer is considered eligible for treatment with Y-90 (a radioactive therapy) combined with atezolizumab and bevacizumab, as determined by the treating team
• People with a good general physical functioning level (ECOG performance status of 0 or 1)
• People with a life expectancy of more than 6 months
• People with adequate blood counts and organ function based on blood tests taken within 14 days before starting treatment, including sufficient white blood cells, lymphocytes, platelets, haemoglobin, liver enzymes, bilirubin, kidney function, and albumin within acceptable ranges (note: people with a known inherited condition called benign ethnic neutropenia or Gilbert disease have adjusted acceptable ranges; confirm with trial site)
• People with HIV who are stable on anti-retroviral therapy, have a CD4 count of 200/μL or higher, and have an undetectable viral load
• People with hepatitis C (HCV) or hepatitis B (HBV) that is absent or controlled
• People who test negative for pregnancy on a blood test within 14 days before starting treatment (for those who could become pregnant)
• People who agree to avoid heterosexual intercourse or use contraception throughout the study period

Who may not be able to join:

• People with an AFP blood level of 1000 ng/mL or higher
• People whose tumour is a mixed cancer type, or whose cancer has spread to blood vessels or outside the liver
• People with a history of cancer spreading to the lining around the brain and spinal cord (leptomeningeal disease)
• People with pain from their tumour that is not under control (those on a stable pain medication routine may still be considered)
• People with severe lung disease, or uncontrolled fluid build-up around the lungs, heart, or abdomen requiring drainage more than once a month (those with a permanent drainage tube already in place may still be considered)
• People with uncontrolled or symptomatic high calcium levels in the blood
• People with an active or past autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, multiple sclerosis, or uncontrolled HIV), with some exceptions for well-controlled conditions such as thyroid disease on replacement hormones, controlled Type 1 diabetes on insulin, or mild skin conditions covering less than 10% of the body that are well managed with low-strength creams
• People with a history of certain lung conditions including idiopathic pulmonary fibrosis, drug-related lung inflammation, or organising pneumonia, or who show signs of active lung inflammation on a chest CT scan at screening
• People with active tuberculosis
• People who have had a significant heart or blood vessel event (such as a heart attack or stroke) within the past 12 months, or who have an unstable heart rhythm or unstable chest pain
• People who have had a major surgical procedure (not related to diagnosis or standard liver cancer care) within 4–6 weeks before starting treatment
• People who have had a core biopsy or minor procedure within 7 days before starting treatment (placement of a vascular access device must be at least 2 days before starting)
• People with a history of another cancer within the past 5 years, except for certain low-risk cancers that have been fully treated (such as early-stage cervical, skin, prostate, bladder, or uterine cancers with a very low risk of spreading)
• People who have had a serious active infection within 4 weeks before starting treatment, or who are currently on intravenous antibiotics
• People who have taken antibiotic treatment (not just preventive antibiotics) within 2 weeks before starting treatment
• People who have had an organ transplant or bone marrow transplant
• People with any other serious medical condition, abnormal test result, or physical finding that could make the treatment unsafe or affect the study results
• People who have received a live vaccine within 4 weeks before starting treatment, or who expect to need one during or within 5 months after finishing atezolizumab
• People who have taken another experimental treatment within 28 days before starting treatment
• People who have previously received certain immune-based cancer therapies, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 treatments
• People who have received immune-boosting medications (such as interferon or IL-2) within 4 weeks or 5 half-lives of the drug before starting treatment
• People who have taken immune-suppressing medications (such as steroids or methotrexate) within 2 weeks before starting treatment, with some exceptions for low-dose or short-course use
• People with a history of severe allergic reactions to certain types of antibody-based medicines
• People with a known allergy to any component of atezolizumab or bevacizumab, including products derived from Chinese hamster ovary cells
• People who have previously received any local or systemic treatment for their liver cancer
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after the last dose
• People with poorly controlled high blood pressure (systolic above 150 mmHg and/or diastolic above 100 mmHg)
• People with a history of hypertensive crisis or severe blood pressure-related brain complications
• People with significant blood vessel disease (such as a large aortic aneurysm or recent arterial blood clot) within 6 months before joining
• People with a history of a severe (Grade 4) blood clot in a vein
• People with a history or current signs of cancer or other disease affecting the brain or nervous system
• People with a history of coughing up significant amounts of blood (2.5 mL or more per episode) within 1 month before screening
• People with a known inherited bleeding disorder or significant clotting problem
• People with a history of an abdominal fistula, bowel perforation, abdominal abscess, or active gastrointestinal bleeding within 6 months before joining
• People with a serious non-healing wound, active ulcer, or untreated broken bone
• People currently taking high-dose aspirin (more than 325 mg/day) or clopidogrel (more than 75 mg/day) within 10 days before starting treatment

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