Phase 3 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:

• Adults aged 18 or older who have signed a consent form to participate
• People with a confirmed diagnosis of hepatocellular carcinoma (a type of liver cancer), confirmed by tissue sample or specific imaging scans
• People whose liver cancer is at an intermediate stage — meaning it cannot be removed by surgery, treated with a liver transplant, or fully destroyed by ablation, but is still suitable for a procedure called TACE (a treatment that delivers cancer-fighting medicine directly to the liver's blood supply)
• People whose cancer does not show a very widespread multi-nodular pattern that would prevent effective TACE treatment
• People whose cancer is not a diffuse, infiltrative type (a specific pattern where tumours spread through the liver without clear borders)
• People with normal blood flow through the main portal vein (the large vein supplying the liver), or only minimal portal vein involvement (Vp1 or Vp2 levels) (confirm with trial site)
• People whose liver cancer has not spread outside the liver
• People who have had liver cancer return after previous surgery, ablation, or TACE, and who — in the treating doctor's judgement — would benefit from further TACE treatment
• People whose cancer has grown beyond certain size/number limits (Milan criteria) who are already on a programme to shrink the cancer before a possible transplant, provided no exclusion criteria apply
• People with liver function classified as Child-Pugh class A or B7, without significant fluid build-up in the abdomen requiring more than 100 mg of spironolactone per day
• People with a general health/activity level rated 0 or 1 on a standard scale (meaning fully active or able to carry out light activity)
• People with adequate blood, liver, and kidney function based on blood tests taken within 7 days before joining the trial
• People with a life expectancy of at least 3 months
• Women of childbearing potential who have a negative pregnancy test within 7 days before joining the trial
• People who have had a recent scope examination of the oesophagus and stomach (within the past 6 months) to check for enlarged veins, with any such veins treated as required beforehand
• People with active hepatitis B virus (HBV) whose virus levels are low (≤2000 IU/mL within 28 days before joining) and who have been on anti-HBV treatment for at least 14 days and are willing to continue throughout the trial
• People with hepatitis C virus (HCV) antibodies, including those with active HCV infection, provided anti-viral HCV treatment is completed before the trial starts and not continued during it
• Women who could become pregnant who agree to use highly effective contraception (failure rate less than 1% per year) or remain abstinent throughout treatment and for at least 5 months after the last dose of atezolizumab, 6 months after the last dose of bevacizumab, or 1 month after the last TACE procedure
• Men who agree to use highly effective contraception or remain abstinent, and to avoid donating sperm, during treatment and for 6 months after the last dose of bevacizumab or 1 month after the last TACE procedure

Who may not be able to join:

• People with specific rare subtypes of liver cancer, including fibrolamellar HCC, sarcomatoid HCC, or a mixed liver-bile duct cancer type (if confirmed by biopsy)
• People who have previously been treated with atezolizumab or bevacizumab (the study drugs)
• People who have previously received certain immune-based cancer treatments (such as PD-1, PD-L1, or CTLA-4 inhibitors, or any other cancer immunotherapy for liver cancer)
• People with significant fluid build-up in the abdomen that requires drainage procedures to manage symptoms; people with stable mild fluid build-up managed by low-dose diuretics (spironolactone up to 100 mg/day) for at least 2 months may still be considered
• People who have had major surgery, an open biopsy, or a serious injury within 28 days before joining, or who are expected to need major surgery during the trial
• People with significant heart disease, a heart attack, or stroke within 3 months before joining; or unstable heart rhythm or unstable chest pain
• People with uncontrolled high blood pressure (blood pressure at or above 150/100 mmHg) that cannot be brought under control with medication; or a history of hypertensive crisis
• People currently taking full-dose blood-thinning or clot-dissolving medications (low-dose preventive anticoagulation may be acceptable — confirm with trial site)
• People who have had a stroke, blood clot in the leg, or pulmonary embolism (clot in the lungs) within 6 months before joining
• People with certain conditions affecting the bile ducts or blood supply to the liver that would make TACE unsuitable, including a history of surgery connecting the bile duct to the bowel, certain bile duct procedures, air in the bile ducts, blockage of the main bile ducts, or blockage of the celiac artery
• People with a serious ongoing infection
• People who have both hepatitis B and hepatitis C at the same time, unless blood tests show the hepatitis C virus is no longer detectable
• People with epilepsy (seizure disorder) requiring ongoing medication
• People who have had a bone marrow transplant or an organ transplant
• People with a history of significant or severe bleeding episodes within 4 weeks before joining, or a known bleeding disorder
• People with wounds, ulcers, or bone fractures that have not healed
• People who require dialysis for kidney failure
• People with a known allergy or serious reaction to any of the study drugs or their components, including reactions to similar antibody-based medicines
• People with HIV/AIDS, with the exception that people who are stable on HIV treatment, have an adequate immune cell count (CD4 above 200 cells/µL), and have undetectable HIV levels may still be considered
• People with active tuberculosis
• People with active lung disease causing ongoing breathing symptoms (interstitial lung disease)
• People with a history of certain types of lung inflammation or scarring (such as idiopathic pulmonary fibrosis, drug-induced pneumonitis, or organising pneumonia), or evidence of active lung inflammation on a recent CT scan
• People with high levels of protein in the urine (above 3.5 g in 24 hours)
• Women who are pregnant or breastfeeding
• People with other serious illnesses or conditions that, in the treating doctor's judgement, would make participation unsafe or interfere with the trial's results
• People with active or past autoimmune diseases (conditions where the immune system attacks the body), such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and others — some exceptions may apply for certain well-controlled skin conditions or thyroid/diabetes conditions (confirm with trial site)
• People who have been taking immune-suppressing medicines within 2 weeks before starting the trial, or who are likely to need them during the trial (some short-term or low-dose exceptions may apply — confirm with trial site)
• People using herbal remedies known to affect liver or major organ function
• People who have received a live vaccine within 4 weeks before joining, or who are expected to need one during the trial or within specified periods after treatment ends
• People diagnosed with another cancer within the past 3 years, except for certain very low-risk cancers that have been fully treated (such as early-stage skin cancer or early cervical changes — confirm with trial site)
• People who have taken part in another clinical drug trial within 28 days before joining
• People with a history of not following medical instructions, or who have conditions (including substance use or psychological/social difficulties) that may affect their ability to participate safely or reliably

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