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 able to give written consent and follow the study requirements.
• People who have been confirmed by lab testing (tissue or cell sample) to have extensive-stage small cell lung cancer (ES-SCLC) with liver spread (metastases) found on imaging at diagnosis.
• People who previously had a type of non-small cell lung cancer with a specific gene mutation (EGFR), which has since changed into small cell lung cancer with liver spread, and who have not yet received chemotherapy or immunotherapy.
• People who have not previously received treatment for ES-SCLC. (People who were previously treated for an earlier, limited stage of the disease may still be considered, provided that treatment was intended to cure and there has been at least six months between the last treatment and the ES-SCLC diagnosis — confirm with trial site.)
• People with measurable tumour(s) visible on imaging scans, based on standard measurement guidelines.
• People with brain tumours that are either treated or untreated but not causing symptoms, provided: the tumours are only in certain areas of the brain (not in the brainstem); there is also measurable disease outside the brain; there has been no bleeding in the brain or spine; no brain radiation was given within the 14 days before starting the study, and no brain surgery within 28 days before starting; and any steroid or anti-seizure medicines being taken are at a low, stable dose.
• People with a general physical functioning level rated 0, 1, or 2 on the ECOG scale (a standard measure of how well a person is able to carry out daily activities — confirm with trial site).
• People whose blood test results within 14 days before starting the study show that their kidneys, blood counts, and liver are functioning adequately (specific lab value thresholds apply — confirm with trial site).
• People with hepatitis C antibodies who have cleared the virus (either through treatment or naturally) and have a negative hepatitis C RNA test. People with untreated hepatitis C may also be considered if the condition is stable and the liver is not at risk — confirm with trial site.
• Women of childbearing potential who have a negative pregnancy blood test before starting the trial.
• Women of childbearing potential who agree to use effective contraception (or remain abstinent) during treatment and for 5 months after the last dose of atezolizumab or 6 months after the last dose of bevacizumab, whichever is later. (Acceptable methods include male sterilisation, contraceptives that stop ovulation, hormone-releasing intrauterine devices, or copper intrauterine devices. Periodic abstinence methods and withdrawal are not considered acceptable.)
• Men with a female partner who is pregnant or could become pregnant who agree to use a condom (or remain abstinent) during chemotherapy treatment and for at least 6 months after the final dose of any study drug, and who agree not to donate sperm during this time.

Who may not be able to join:

• People who have had cancer spread to the lining of the brain or spinal cord (leptomeningeal disease).
• People who have had a blood clot in a deep vein, a clot in the lungs, or another serious clotting event in the 3 months before starting the trial.
• People whose blood pressure is not adequately controlled (above 150/100 mmHg), even after trying blood pressure medication.
• People whose tumour appears to be growing into or pressing against major blood vessels.
• People with a history of a severe hypertensive crisis or a condition involving swelling and changes in the brain caused by very high blood pressure (hypertensive encephalopathy).
• People who have had serious blood vessel disease (such as a large aortic aneurysm needing surgery, or a recent arterial blood clot) within 6 months before joining.
• People who have coughed up significant amounts of fresh red blood within 1 month before joining.
• People who have a condition that causes abnormal bleeding or blood clotting (not related to blood-thinning medication).
• People currently taking or who have recently (within 10 days) taken high-dose aspirin (over 325 mg/day) or certain other blood-thinning medicines such as dipyridamole, ticlopidine, clopidogrel, or cilostazol.
• People on full-dose blood-thinning medication (oral or injected) that has not been at a stable dose for at least 2 weeks. (Stable therapeutic anticoagulation may be permitted under certain conditions — confirm with trial site. Low-dose preventive anticoagulation for keeping IV lines open may also 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 7 days before the first dose of bevacizumab.
• People with a history of an abnormal opening (fistula) in the abdomen or between the airway and oesophagus, or a bowel perforation (a hole in the gut), within 6 months before joining.
• People with signs of bowel obstruction, or who routinely need IV fluids, IV nutrition, or tube feeding.
• People with a serious wound that is not healing, an active ulcer, or an untreated broken bone.
• People with too much protein in their urine (above specified levels on testing — confirm with trial site).
• People with an active or past autoimmune disease or immune system deficiency (such as lupus, rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, and many others). Some exceptions apply, including: people with thyroid problems managed with hormone replacement; people with controlled Type 1 diabetes on insulin; people with rheumatoid arthritis whose symptoms are well controlled on a stable pain regimen; and people with certain skin conditions (such as eczema or psoriasis) limited to the skin, well controlled with low-strength creams, affecting more than 10% of body surface area, and not requiring stronger treatments in the past 12 months — confirm with trial site.
• People with a history of certain lung conditions including idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, or unexplained lung inflammation, or who show signs of active lung inflammation on a recent CT scan. (A history of scarring from radiation in a treated area is generally permitted — confirm with trial site.)
• People with active tuberculosis.
• People who have had significant heart or blood vessel problems (such as a heart attack, stroke, or certain heart conditions rated Class II or higher) within 3 months before starting the trial, or who have an unstable heart rhythm or unstable chest pain.
• People who have had a major operation (other than for diagnostic purposes) within 4 weeks before starting the trial, or who are expected to need major surgery during the study.
• People who have had another cancer in the past 3 years, with some exceptions for certain low-risk cancers that were treated with the intent to cure (confirm with trial site).
• People who have had a serious infection within 4 weeks before starting the trial, including those requiring hospitalisation, bloodstream infection, or severe pneumonia.
• People who have been treated with antibiotic medicines (not preventive antibiotics) within 2 weeks before starting the trial.
• People who have previously received a stem cell or solid organ transplant from another person.
• People with any other condition, finding, or test result that could make participation unsafe or affect the study results (confirm with trial site).
• People with known HIV infection, unless they are on effective antiviral treatment and a recent viral load test (within the past 6 months) shows the virus is undetectable.
• People with known chronic hepatitis B infection.
• People who have received a live vaccine (such as the nasal flu vaccine) within 4 weeks before starting the trial, or who would need one during treatment with atezolizumab or within 5 months of its final dose.
• People who have taken immune-suppressing medicines (such as corticosteroids, methotrexate, or similar drugs) within 2 weeks before starting the trial, or who expect to need them during the study. (Several exceptions apply — confirm with trial site.)
• People with a history of a severe allergic reaction to certain types of laboratory-produced antibody treatments.
• People with a known allergy to the specific components used to make atezolizumab, including products derived from Chinese hamster ovary cells.
• People with a known allergy to any components of bevacizumab.
• People currently taking or planning to take traditional herbal medicines.
• People who have received another experimental treatment within 28 days before starting the trial.

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