Phase 3 Stomach Cancer Trial, Recruiting

Written by an AI model from the 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 are able to give signed consent to participate
• People who, in the trial team's judgment, are able to follow the study procedures
• People who have been diagnosed with one of the following cancers, confirmed by laboratory testing: colorectal cancer, stomach cancer, pancreatic cancer, liver cancer (hepatocellular carcinoma), or bile duct/gallbladder cancer
• People whose cancer was treated with the intention of a complete cure (including surgery and any recommended treatments before or after surgery), and where the treating doctor considers treatment to be complete — including people considered at high risk of the cancer coming back
• People with liver cancer (hepatocellular carcinoma) whose liver function scores at a level called "Child Pugh A" at the time of screening
• People who had a limited number of cancer sites spread to other parts of the body, where all of those sites were treated with curative intent and no cancer is currently visible on scans
• People who have had a full physical examination and imaging scans (chest, abdomen, and pelvis) within the past 28 days showing no signs of remaining or returned cancer
• People who have had a specific blood test called Signatera ctDNA that came back positive within the past 28 days and within one year of finishing all curative treatment — this means tiny traces of cancer DNA were detected in the blood even though scans appear clear
• People whose general physical fitness is rated at a level called ECOG 0, 1, or 2, meaning they are able to care for themselves and are up and about for at least part of the day (confirm with trial site)
• People whose blood test results, taken within the past 28 days, show that the blood, liver, and kidneys are functioning at acceptable levels as defined by the trial (confirm with trial site for specific values)
• People who are on a stable blood-thinning (anticoagulant) medication regimen
• People who tested negative for HIV, or who tested positive but are stable on HIV treatment, have an adequate immune cell count, and have an undetectable amount of virus in their blood
• People with certain treated and well-managed hepatitis B or hepatitis C infections may be considered (confirm with trial site)
• Women who are not pregnant, confirmed by a blood test within the past 28 days
• Women who are not breastfeeding
• Women who could potentially become pregnant and agree to use highly effective contraception during treatment and for at least 5 months after the last dose of atezolizumab and 6 months after the last dose of bevacizumab, and who agree not to donate eggs during this period
• Men who agree to use highly effective contraception or remain abstinent during treatment and for 6 months after the last dose of bevacizumab, and who agree not to donate sperm during this period

Who may not be able to join:

• People who have any sign of remaining, returning, or spread cancer found on physical examination, imaging, or biopsy within the past 28 days
• People who were eligible for but did not receive all recommended standard cancer treatments within the expected timeframe, unless there was a valid medical reason or it was the person's preference
• People with an active autoimmune disease or immune system deficiency (such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions), with some exceptions for well-controlled thyroid conditions, well-controlled Type 1 diabetes, or mild skin conditions meeting specific criteria (confirm with trial site)
• People with a history of certain lung scarring or inflammation conditions, or who show signs of active lung inflammation on a recent chest scan (a history of radiation-related lung scarring is allowed)
• People with active tuberculosis
• People with significant heart or blood vessel problems, such as a stroke or heart attack in the past 12 months, unstable chest pain, moderate-to-severe heart failure, or serious heart rhythm problems not controlled by medication
• People with significant blood vessel disease (such as a large aortic aneurysm or recent arterial blood clot) within the past 6 months
• People with blood pressure that is not adequately controlled (above 150/100 mmHg on average across multiple readings and sessions), though medication to bring blood pressure under control is permitted
• People with a history of a hypertensive crisis or hypertensive encephalopathy (a severe, dangerous spike in blood pressure)
• People with a history of a serious blood clot in a vein, graded as severe (Grade 4 or higher)
• People with a history of, or current signs of, bleeding in the brain or spinal cord
• People who have coughed up a significant amount of blood (2.5 mL or more) within the past month
• People with a known inherited bleeding disorder or significant clotting problems
• People currently taking high-dose aspirin (more than 325 mg/day) or clopidogrel (more than 75 mg/day) within 10 days before starting treatment
• People taking a non-steroidal anti-inflammatory drug (NSAID) every day on a regular basis (occasional use for headaches or joint pain is acceptable)
• People who have had major surgery or a significant injury within the past 28 days, or who are expected to need major surgery during the trial
• People who have had a local treatment to the liver or another organ (such as ablation or chemoembolization) within the past 28 days, or who have not recovered from such a procedure
• People with untreated or incompletely treated swollen veins in the oesophagus or stomach that are bleeding or at high risk of bleeding, particularly those with liver cancer, cirrhosis, or related conditions
• People who have had a bleeding episode from oesophageal or stomach varices within the past 6 months
• People who have had a minor surgical procedure (other than placement of a vascular access device) within the past 7 days
• People whose vascular access device was placed less than 2 days before starting treatment
• People currently receiving intravenous (IV) antibiotics for an active infection at the time treatment would begin
• People who have had a serious infection within the past 4 weeks, including hospitalisation for infection, bacteria in the bloodstream, or severe pneumonia
• People with a history of an abdominal fistula, bowel perforation, abdominal abscess, or active gastrointestinal bleeding within the past 6 months (some exceptions may apply — confirm with trial site)
• People with a wound that is not healing, an active ulcer, or an untreated broken bone
• People with a separate previous cancer diagnosis, with some exceptions for cancers that were fully treated at least 5 years ago with no further treatment needed, or certain low-risk cancers such as early cervical changes, non-melanoma skin cancer, localised prostate cancer, or early-stage uterine cancer (confirm with trial site)
• People who have previously had a bone marrow transplant or a solid organ transplant from a donor
• People with any other serious disease, active infection, or health condition that the trial team considers would make participation unsafe or affect the reliability of results
• People who have received a live vaccine within the past 4 weeks, or who are expected to need one during atezolizumab treatment or within 5 months after the final dose
• People who have received another experimental treatment within the past 28 days
• People who have previously been treated with certain immune checkpoint or immune-stimulating therapies, including anti-CTLA-4, anti-PD-1, or anti-PD-L1 antibodies
• People who have received immune-stimulating medications (such as interferon or IL-2) within the past 4 weeks or within 5 half-lives of the drug, whichever is longer
• People who have taken immune-suppressing medications (such as corticosteroids, methotrexate, or similar drugs) within the past 2 weeks, or who are expected to need them during the trial — with some specific exceptions (confirm with trial site)
• People with a history of a severe allergic reaction to certain types of antibody-based medications
• People with a known allergy to the study drugs (atezolizumab or bevacizumab) or their ingredients, including products derived from Chinese hamster ovary cells
• Women who are pregnant, breastfeeding, or planning to become pregnant during treatment or within 5 months after the last dose of atezolizumab or 6 months after the last dose of bevacizumab
• People with uncontrolled high calcium levels in the blood
• People with a history of cancer spreading to the lining of the brain or spinal cord (leptomeningeal disease)
• People with cancer-related pain that is not controlled
• People with uncontrolled fluid build-up around the lungs, heart, or abdomen that requires drainage more than once a month (people with a permanent drainage catheter in place may be eligible)
• People with active, untreated, or worsening cancer spread to the brain or spinal cord, unless the spread was previously treated with curative intent, shows no remaining disease, and meets specific additional criteria (confirm with trial site)

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