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 are willing and mentally able to give written consent before any study-related testing begins.
• Adults aged 21 to 90 at the time of signing the consent form.
• People who are able to attend scheduled visits and follow study procedures.
• People diagnosed with hepatocellular carcinoma (liver cancer, HCC) or a closely related variant, who have had surgical removal of the tumour between 4 and 12 weeks before the start of treatment — with surgery as the only treatment used (no combination with other procedures such as ablation).
• People whose liver cancer diagnosis has been confirmed both clinically and by laboratory examination of tissue, with surgical margins confirmed as clear (no cancer cells at the edges of the removed tissue), documented in a pathology report.
• People who have been confirmed cancer-free by physical examination and imaging scans within 4 weeks before treatment starts, with no signs of remaining or returning disease.
• People whose cancer has not grown into the major blood vessels of the liver in a large-scale way (confirm with trial site for specific vessel criteria).
• People whose cancer has not spread outside the liver, confirmed by CT or MRI scans of the chest, abdomen, pelvis, and head before treatment starts.
• People who have fully recovered from their surgery within 4 weeks before treatment starts.
• People whose cancer is considered high risk for returning after surgery, either because the tumour size and number exceed a specific threshold (called the "up-to-7" criteria), or because there is limited blood vessel involvement of a specific type (Vp1 or Vp2) (confirm with trial site for details).
• People who have tested negative for HIV.
• People with a documented hepatitis B or C status: those with active hepatitis B must have virus levels below a certain threshold and be on or willing to start antiviral treatment at least 14 days before treatment begins; those with hepatitis C (whether past or ongoing) may still be eligible (confirm with trial site for details).
• People who are willing to have an upper gastrointestinal scope procedure (a camera examination of the oesophagus, stomach, and upper small bowel) either before or after surgery, and to have any enlarged veins treated if found.
• People who are willing to have a heart tracing (ECG) either before or after surgery, prior to treatment starting.
• People whose liver function falls within a specific scoring range (Child-Pugh A, up to 6 points) with no fluid build-up in the abdomen before surgery.
• People with a good general performance level, able to carry out normal daily activities with at most minor limitations (ECOG performance status 0–1).
• People whose blood, kidney, and liver function results meet specific minimum levels measured within 7 days before treatment starts (confirm with trial site for exact values).
• People estimated to have a life expectancy of at least 3 months without active treatment.
• People assessed by the trial site investigator as suitable for the study treatment.
• Female patients who are either post-menopausal, or if pre-menopausal, have a negative pregnancy test and agree to use two forms of contraception during treatment and for at least 5 months after the last dose of atezolizumab or 6 months after the last dose of bevacizumab, whichever is later.
• Male patients who are either surgically sterile or, if sexually active with a pre-menopausal female partner, agree to use contraception during treatment and for 6 months after the last dose of bevacizumab.

Who may not be able to join:

• People who are unable or unwilling to give informed consent, or who decline blood tests.
• People who have any remaining, returning, or spread cancer before treatment begins.
• People with clinically significant fluid build-up in the abdomen or other signs of liver failure at the time of enrolment.
• People with a history of confusion or altered mental state caused by liver disease (hepatic encephalopathy).
• People who have had a bleeding episode from untreated or incompletely treated enlarged veins in the oesophagus or stomach before treatment starts.
• People with an active or historical autoimmune disease or immune deficiency (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and others) — though some exceptions apply for well-controlled thyroid conditions, Type 1 diabetes, or limited skin conditions (confirm with trial site).
• People with a history of certain lung scarring or inflammation conditions, or who show signs of active lung inflammation on screening scans.
• People with significant heart or blood vessel disease, including a heart attack or stroke within the 3 months before treatment starts, or unstable heart rhythm or chest pain.
• People with a history of another cancer within the past 5 years, except for certain low-risk cancers that have been fully treated (confirm with trial site for exceptions).
• People with active tuberculosis at the time of screening.
• People who have had a serious infection within 4 weeks before treatment starts, including infections requiring hospitalisation.
• People who have taken antibiotic treatment by mouth or through a drip within 2 weeks before treatment starts — though those on preventive antibiotics may still be eligible.
• People who have had a bone marrow or organ transplant in the past.
• People currently on a waiting list for a liver transplant.
• People with any other serious medical condition, abnormal test result, or other finding that the trial site determines makes participation unsafe or would affect the results.
• People with a combined infection of both hepatitis B and hepatitis C, or a hepatitis D infection.
• People with severely elevated calcium levels in the blood that are not under control.
• People with a history of severe allergic reactions to certain types of laboratory-made antibody treatments.
• People with a known allergy to components of the study drugs atezolizumab or bevacizumab.
• People who have received any prior treatment for liver cancer before their surgery, including previous liver surgery (within the last 5 years), chemotherapy, radiation, immunotherapy, or other local treatments — with some specific exceptions (confirm with trial site).
• People who have received or plan to receive a live vaccine within 4 weeks before treatment starts, or who may need one during the study or within 5 months after the last dose of atezolizumab.
• People who have received another experimental treatment within 4 weeks before treatment starts.
• People who have previously received certain immune-based cancer treatments, including anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies.
• People who have received immune-stimulating treatments (such as interferon or interleukin-2) within a certain period before treatment starts.
• People who have received immune-suppressing medications within 2 weeks before treatment starts, or who are expected to need them during the study — with some limited exceptions (confirm with trial site).
• People with poorly controlled high blood pressure (consistently above 150/100 mmHg) — though treatment to bring blood pressure under control may allow eligibility.
• People with a history of a hypertensive crisis or brain swelling caused by high blood pressure.
• People with significant blood vessel disease such as a large artery bulge (aneurysm) or recent blood clot in an artery within 6 months before treatment starts.
• People who have coughed up significant amounts of blood within 1 month before treatment starts.
• People with a known bleeding disorder or serious clotting problem.
• People currently using full-dose blood-thinning or clot-dissolving medications for treatment purposes within 10 days before treatment starts — though some preventive uses may be permitted (confirm with trial site).
• People who have had a core biopsy or minor surgical procedure (other than placement of a vascular access device) within 3 days before treatment starts.
• People with a history of a hole or abnormal connection in the digestive tract, or an abscess in the abdomen, within 6 months before treatment starts.
• People with unexplained free air in the abdomen.
• People with a serious non-healing wound, active ulcer, or untreated bone fracture.
• People who have had or are expected to need a major surgical procedure within 4 weeks before treatment starts, or during the study.
• People with a history of a significant inflammatory condition in the abdomen (such as peptic ulcer disease, diverticulitis, or colitis) within 6 months before treatment starts.
• Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study or within 5 months after the last dose of atezolizumab or 6 months after the last dose of bevacizumab.

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