Phase 2 Stomach 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 to take part voluntarily, sign a consent form, and follow the study requirements
• Adults aged 18 or older, of any gender
• People who have been confirmed by tissue or cell testing to have advanced (stage IV) stomach cancer or cancer at the junction of the stomach and oesophagus
• People whose tumour tests positive for a protein called PD-L1 and has a low tumour microenvironment score (a measure of the tumour's biological features — confirm with trial site)
• People who have not had any previous systemic treatment for this cancer, or who had prior chemotherapy or radiotherapy aimed at curing the cancer but whose cancer returned more than 6 months after that treatment ended
• People with a general health and activity level rated between 0 and 2 on a standard medical scale (meaning able to carry out at least some daily activities — confirm with trial site)
• People expected to live at least 12 weeks
• People whose recent blood test results (without a blood transfusion in the past 14 days) show adequate levels of white blood cells, platelets, and haemoglobin, and show that the liver and kidneys are functioning within acceptable ranges
• People of childbearing potential who are willing to use effective contraception during the study

Who may not be able to join:

• People who have previously received treatments that target certain immune checkpoint pathways, such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 drugs
• People who have previously received certain anti-vascular targeted drug therapies such as fruquintinib or regorafenib
• People who had major surgery within 4 weeks before starting the trial, or who had radiotherapy, radiofrequency ablation, or other experimental treatments within the previous 2 weeks
• People who received a live vaccine within 4 weeks before starting the trial (seasonal flu vaccines using inactivated virus are generally permitted — confirm with trial site)
• People with a history of severe intolerance or serious side effects from any of the drugs used in this study
• People with a known allergy to the study drug or any of its ingredients
• People whose stomach or gastroesophageal junction cancer tests positive for a protein called HER2
• People who have had another cancer in the past 5 years or currently have another cancer, with some exceptions for certain very early or cured skin and surface cancers
• People with known cancer that has spread to the brain or the lining around the brain
• People who are preparing for or have previously had an organ or bone marrow transplant
• People with a known history of HIV infection
• People with a history of substance abuse or recreational drug use
• People with existing lung conditions such as interstitial lung disease, dust-related lung disease, radiation-related lung damage, drug-related lung damage, or severely reduced lung function
• People with a known active or suspected autoimmune disease, unless their condition is stable and does not require immune-suppressing medication
• People who have needed higher-dose steroid tablets or other immune-suppressing medications within the 2 weeks before starting the trial or during the study (low-dose or inhaled steroids may be permitted — confirm with trial site)
• People who have had an active infection requiring treatment within the 2 weeks before starting the trial
• People with active heart disease, including a heart attack or severe chest pain in the past 6 months, a weakened heart pump on echocardiogram, or poorly controlled irregular heartbeat
• People who have had significant bleeding, coughing up blood within the past 3 months, or a blood clot event such as a stroke, deep vein thrombosis, or pulmonary embolism within the past 6 months, or who require long-term blood-thinning or antiplatelet medication at higher doses
• People with any other significant medical condition, abnormal test results, or other circumstances that the trial investigator considers unsuitable for participation
• People with any situation that the investigator believes could put them at risk or affect the reliability of the trial results
• People who are pregnant, breastfeeding, or who may become pregnant

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