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 have been fully informed about the study and have signed a consent form agreeing to take part
• People whose stomach or stomach-oesophagus junction cancer has been confirmed by a stomach camera (gastroscopy) and biopsy as a locally advanced type called adenocarcinoma
• People whose cancer has been classified at a specific intermediate-to-advanced stage (cT3/4a Nx, or T2 N2/3, M0 using standard staging guidelines), with no evidence of spread to distant parts of the body
• People who have a current Helicobacter pylori (H. pylori) bacterial infection in the stomach, confirmed by one of several accepted tests (such as a breath test, stool test, tissue test, or blood antibody test)
• People aged 18 to 75, of any sex
• People who are in reasonably good general health, as measured by a standard performance scale (ECOG score of 0 or 1, meaning fully active or able to carry out light activity)
• People whose organ function is sufficient to safely undergo major abdominal surgery
• People with an expected survival of at least 6 months
• People whose recent blood test results (taken within 7 days before joining) meet specific required levels for white blood cells, red blood cells, platelets, liver function, kidney function, and blood clotting
• People who are able to cooperate with the endoscopy, blood tests, and scans required by the study
• Women who could become pregnant must agree to use contraception from the time of signing the consent form until at least 6 months after the last dose of study treatment, and must agree not to breastfeed during this same period; men must agree to use contraception from the first dose until at least 6 months after the last dose of study or chemotherapy treatment

Who may not be able to join:

• People whose cancer has reached Stage IV or has been judged by the treating doctor to be unable to be surgically removed
• People who have had, or currently have, another active cancer within the past 5 years
• People who have previously had, or are planning to have, an organ or bone marrow transplant
• People who have had a heart attack within the past 6 months, or who have a poorly controlled irregular heartbeat (including specific abnormal readings on a heart trace)
• People with severe heart failure (classified as NYHA Class III or IV) or whose heart pumping function is measured as below 50% on an ultrasound
• People with active tuberculosis (TB), a history of active TB within the past year, or a history of TB more than one year ago that was not properly treated
• People with a known active or suspected condition where the immune system attacks the body (autoimmune disease), unless the condition is currently stable and not requiring immune-suppressing medication
• People who have received a live vaccine within 28 days before the first dose (standard inactivated flu vaccines are an exception)
• People who have needed high-dose steroid tablets or other immune-suppressing medicines within 14 days before the first dose or during the study (low-dose, inhaled, or topical steroids may be acceptable — confirm with trial site)
• People who are currently in another clinical trial, or whose previous clinical trial ended fewer than 14 days before starting this study
• People with a known history of severe allergic reactions to any ingredient in the study medicines
• People with a known history of abusing substances or drugs (people who have stopped drinking alcohol may still be eligible)
• People with other serious medical or psychiatric conditions that, in the treating doctor's judgement, would make participation unsafe or unsuitable

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