Phase 3 Stomach Cancer Trial, Completed

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 have been diagnosed with locally advanced, inoperable, or metastatic stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed through a tissue or cell sample, with known PD-L1 test results.
• People whose cancer has tested negative for a protein called HER2.
• People whose cancer can be measured on scans, according to a standard set of measurement rules used in cancer research.
• People who have provided a stored or newly taken tumour tissue sample that has not previously been treated with radiation, and that is suitable for biomarker testing.
• People who have provided tumour tissue for an additional genetic marker test called microsatellite instability (MSI) analysis.
• People who are reasonably active and able to carry out daily activities, based on a standard health scoring system (a score of 0 or 1), assessed within 3 days before starting the trial.
• People whose kidneys, liver, and other organs are functioning well enough, confirmed by blood tests taken within 10 days before starting the trial.
• Male participants who agree to use contraception during treatment and for 95 days after the last chemotherapy dose, and who agree not to donate sperm during this period.
• Female participants who are not pregnant or breastfeeding, and who either cannot become pregnant or agree to use contraception during treatment and for 180 days after the last chemotherapy dose or 120 days after the last dose of the study drug pembrolizumab, whichever is later, and who agree not to donate or store eggs for reproduction during this period.

Who may not be able to join:

• People whose stomach cancer is of the squamous cell or undifferentiated type.
• People who have had major surgery, an open biopsy, or a serious physical injury within 28 days before joining, or who have not yet fully recovered from a previous surgery.
• People who already have nerve damage in their hands or feet rated above a mild level (above Grade 1).
• Women who could become pregnant and have a positive pregnancy test in the days before starting the trial.
• People who have already received treatment specifically for advanced or metastatic stomach or gastroesophageal junction cancer (note: prior treatment given before or after surgery may be acceptable if it was completed at least 6 months before joining — confirm with trial site).
• People who have previously been treated with certain immune checkpoint drugs, including anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or similar immune-targeting therapies.
• People who have received any systemic cancer treatment or experimental therapy within 4 weeks before joining, or who have not recovered from side effects of previous cancer treatments.
• People who have had radiation therapy within 2 weeks before starting the trial, or who have not recovered from radiation-related side effects (a shorter 1-week gap may apply in certain limited cases — confirm with trial site).
• People who have received a live or live-attenuated vaccine within 30 days before the first dose of the study treatment.
• People who are currently in, or have recently been in, another clinical trial using an experimental treatment or device within 4 weeks before starting.
• People with an immune system deficiency, or who are currently taking steroid medicines or other treatments that suppress the immune system within 7 days before starting.
• People who have another cancer that is active or has required treatment within the past 5 years, with the exception of certain treated skin cancers or localised cancers that have been potentially cured.
• People with active cancer that has spread to the brain or the lining of the brain or spinal cord.
• People who have had a severe allergic reaction (Grade 3 or higher) to the study drug pembrolizumab or any of its ingredients.
• People with an active autoimmune disease that has needed systemic medical treatment in the past 2 years.
• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People with an active infection that requires treatment through a drip or tablets prescribed by a doctor.
• People with a known history of HIV infection.
• People with known active or surface-antigen-positive Hepatitis B, or active Hepatitis C infection.
• People with a known history of active tuberculosis.
• People with low blood levels of potassium, magnesium, or calcium.
• People who are pregnant, breastfeeding, or planning to conceive or father children during the study period and for up to 180 days after the last chemotherapy dose or 120 days after the last pembrolizumab dose, whichever is later.
• People who have received an organ or tissue transplant from another person.
• People who have had a severe allergic reaction (Grade 3 or higher) to any of the chemotherapy drugs used in the study, such as 5-fluorouracil or capecitabine.
• People taking cisplatin who have moderate or greater hearing loss confirmed by a hearing test (Grade 2 or above).
• People with a known psychiatric condition or substance use disorder that would make it difficult to follow the trial requirements.
• People with any other medical condition, treatment history, or lab result that the treating doctor believes could interfere with the trial or would not be in the person's best interest (confirm with trial site).

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