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:

• Adults aged 18 or older at the time of signing the consent form
• People who have liver cancer (hepatocellular carcinoma, or HCC) that cannot be surgically removed and has spread beyond what is considered the Milan criteria (a set of size and number limits used in transplant planning), with measurable or assessable disease on scans
• People whose liver cancer has been confirmed by a tissue sample (biopsy), with no cancer spread outside the liver. A fresh biopsy may be requested, but older stored tissue samples may also be accepted
• People who have had a previous local treatment to the liver (such as ablation or radiation) are still eligible if new tumours or recurrence are present
• People who meet the criteria to be considered for a liver transplant (as defined by the trial site)
• People who are suitable to receive a procedure called TACE (a treatment that delivers chemotherapy directly into the liver's blood supply)
• People whose liver function scores at a level of Child-Pugh A6 or better (a measure of how well the liver is working)
• People with a general fitness score of 0 or 1 on the ECOG scale, meaning they are fully active or restricted in strenuous activity but able to carry out light work
• People with a life expectancy of at least 6 months
• People whose recent blood test results (within the past 14 days) show adequate blood cell counts, liver function, kidney function, and blood clotting levels as assessed by the trial site
• People with no Grade 2 or higher varicose veins in the oesophagus or stomach (confirmed by a camera test called an endoscopy within the past 6 months)
• People with no history of coughing up significant amounts of blood (half a teaspoon or more) in the past month
• People who test negative for HIV at screening or transplant assessment
• People who test negative for active Hepatitis B infection at screening or transplant assessment (specific blood tests will be used to confirm this)
• Women who could become pregnant must agree to use highly effective contraception or remain abstinent during treatment and for 6 months after the last dose of study medication (or until the end of the study if a liver transplant is received)
• Men with a pregnant partner or a partner who could become pregnant must agree to use a condom or remain abstinent, and must not donate sperm, during treatment and for 6 months after the last dose (or until the end of the study if a liver transplant is received)
• Women who could become pregnant must have a negative pregnancy test within 14 days before starting study treatment
• People who are willing and able to follow all study procedures for the full duration of the trial

Who may not be able to join:

• People whose liver cancer is of specific subtypes, including fibrolamellar HCC, sarcomatoid HCC, or a mixed type involving bile duct cancer (cholangiocarcinoma)
• People who have previously received any systemic (whole-body) treatment for liver cancer
• People who have had, or are planned to have, a transplant of more than one organ, a previous solid organ transplant, or a stem cell transplant
• People with a history of a severe (Grade 4 or higher) blood clot in the veins
• People with a history or current signs of central nervous system conditions (such as seizures) that are not related to cancer and are not well controlled with standard treatment
• People with moderate or severe fluid build-up in the abdomen (ascites)
• People with a history of hepatic encephalopathy (a condition where the liver cannot filter toxins, affecting brain function)
• People with poorly controlled high blood pressure (above 150/100 mmHg)
• People with a history of a hypertensive crisis or high blood pressure affecting the brain
• People with significant blood vessel disease (such as a large aortic aneurysm or recent arterial blood clot) within the past 6 months
• People with significant heart disease, a recent heart attack, or stroke within the past 3 months, or unstable heart rhythm or chest pain
• People with a known inherited bleeding disorder or significant clotting problems (when not on blood-thinning medication)
• People who have had major surgery, a significant injury, or an open biopsy within 28 days before starting treatment, or who are expected to need major surgery during the treatment phase. Minor procedures must have been completed at least 7 days before starting treatment
• People with a history of an abnormal opening (fistula) in the abdomen, a hole in the gut (GI perforation), an abdominal abscess, untreated or Grade 2 or higher oesophageal or stomach varices, or active gut bleeding within the past 6 months
• People with untreated or incompletely treated varicose veins in the oesophagus or stomach that are bleeding or at high risk of bleeding (all varices must be assessed and treated before joining)
• People with a serious non-healing wound, an active ulcer, or an untreated broken bone
• People who have had another cancer within the past 5 years, except for certain localised skin cancers (such as basal cell or squamous cell carcinoma)
• People currently taking high-dose aspirin (more than 325 mg per day) or clopidogrel (more than 75 mg per day) within 10 days before starting treatment
• People who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 6 months after the final dose
• People with uncontrolled fluid build-up around the lungs or heart, or in the abdomen, requiring drainage more than once a month (people with certain indwelling drainage tubes may still be eligible — confirm with trial site)
• People with uncontrolled or symptomatic high calcium levels in the blood
• People with an active or historical autoimmune disease or immune deficiency condition (such as lupus, rheumatoid arthritis, multiple sclerosis, or inflammatory bowel disease), with some exceptions for well-controlled thyroid conditions and certain mild skin conditions — confirm with trial site
• People with a history of certain lung conditions including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or active lung inflammation seen on a recent CT scan
• People with active tuberculosis
• People with any other serious illness, abnormal test result, or condition that the trial team considers would make participation unsafe or affect the trial results
• People who have received a live attenuated vaccine (such as the nasal flu vaccine) within 4 weeks before starting treatment, or who expect to need one during treatment or within 5 months after the last dose of one of the study drugs
• People currently receiving antiviral treatment for Hepatitis B
• People who have previously been treated with certain immune-based therapies, including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or CD137 activating treatments
• People who have received immune-stimulating treatments (such as interferon or IL-2) within 4 weeks or 5 half-lives of the drug before starting treatment
• People who have received immune-suppressing medications (such as steroids, methotrexate, or anti-TNF drugs) within 2 weeks before starting treatment, or who are expected to need them during the treatment phase — some exceptions apply (confirm with trial site)
• People with a history of a severe allergic (anaphylactic) reaction to certain types of antibody-based medicines
• People with a known allergy or sensitivity to any ingredient in the study drugs atezolizumab or bevacizumab
• People who are unable to follow the study procedures or attend follow-up visits
• People with an active infection that is being treated with intravenous (IV) antibiotics within 2 weeks before starting treatment (people on preventive antibiotics may still be eligible — confirm with trial site)
• People who have had a severe infection (including hospitalisation for infection, blood infection, or severe pneumonia) within 4 weeks before starting treatment
• People with a history of cancer spreading to the lining around the brain and spinal cord (leptomeningeal disease)
• People with unexplained free air in the abdomen detected on imaging
• People with a history of an inflammatory condition in the abdomen (such as active peptic ulcer disease, diverticulitis, or colitis) within the past 6 months
• People who take anti-inflammatory painkillers (NSAIDs) daily on a regular basis (occasional use for things like headaches is acceptable)
• People with uncontrolled pain related to their cancer (pain must be managed on a stable medication regimen before joining)

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