Phase 3 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 aged 18 to 70 years old (any gender).
• People who have given written consent to participate in the trial.
• People with laboratory-confirmed, previously untreated HER2-negative stomach cancer or cancer at the junction of the stomach and oesophagus (a specific area where the two meet), at a particular stage of disease (spread to nearby tissues and lymph nodes but not to distant parts of the body), where the cancer is mainly of a type called adenocarcinoma. Only certain subtypes of junction cancers (Siewert type II or III) are eligible, and type II only if chest surgery would not be required (confirm with trial site).
• People with a good general health and activity level, as measured by a standard medical score (ECOG performance status of 0 or 1, meaning fully active or able to carry out light activities).
• People whose blood counts meet specific levels — including haemoglobin, white blood cell count, and platelet count — without having needed a blood transfusion or blood-boosting medications in the past 14 days (confirm specific values with trial site).
• People whose liver and kidney function test results fall within acceptable ranges as set by the trial (confirm specific values with trial site).
• Women who are able to become pregnant must have had a negative pregnancy test within 7 days before joining and must agree to use reliable contraception during the trial and for 8 weeks after the last dose. Men must also agree to use contraception during the trial and for 8 weeks after the last dose, or have had surgical sterilisation.

Who may not be able to join:

• People whose cancer has spread to distant organs or has spread throughout the lining of the abdomen.
• People with an active or previously diagnosed autoimmune or inflammatory condition (such as inflammatory bowel disease, lupus, rheumatoid arthritis, Crohn's disease, Graves' disease, uveitis, or similar conditions), with some possible exceptions such as vitiligo or hair loss conditions — eligibility in these cases would need to be confirmed with the trial site.
• People who have had another cancer in the past 5 years or currently have another cancer, unless it was a fully treated localised cancer such as certain skin cancers, early-stage bladder cancer, or carcinoma in situ of the cervix, breast, or prostate.
• People who are planning to have, or have previously had, an organ or bone marrow transplant.
• People with serious uncontrolled health conditions, including ongoing infections (such as tuberculosis, hepatitis B or C, or pneumonia), uncontrolled high blood pressure, unstable heart conditions, uncontrolled irregular heartbeat, active lung inflammation, or severe ongoing diarrhoea.
• People currently taking immune-suppressing medications, including steroid tablets above a certain dose, within 2 weeks before joining the trial.
• People who have previously received chemotherapy containing platinum or fluorouracil, targeted cancer therapy, radiotherapy to the cancer being studied in this trial, or any prior immunotherapy involving PD-1 or PD-L1 drugs.
• People who have difficulty taking medication by mouth, such as those who cannot swallow, or who have chronic diarrhoea or a bowel obstruction.
• People who have had significant bleeding in the past 3 months — such as vomiting blood or passing black stools — or who are considered at high risk of bleeding due to conditions like stomach perforation, bowel perforation, or large ulcers, or who have active stomach ulcers with a positive stool blood test result.
• People with high blood pressure that cannot be controlled with a single blood pressure medication, a history of unstable chest pain (angina), a new angina diagnosis in the past 3 months, a heart attack in the past 6 months, certain types of irregular heart rhythm, or heart failure of a significant level. Also, people whose heart pumping function (left ventricular ejection fraction) is measured below 50%.
• People whose urine tests show a significant level of protein, confirmed by a 24-hour urine collection test.
• People with wounds that have not healed over a long period, or fractures that have not fully healed.
• People with abnormal blood clotting or a tendency to bleed. People taking blood-thinning medications such as warfarin or heparin are generally excluded, though low-dose warfarin or low-dose aspirin for prevention may be allowed if clotting levels are within an acceptable range (confirm with trial site).
• People who have had a blood clot event in the past year, such as a stroke, mini-stroke (TIA), deep vein thrombosis, or pulmonary embolism (with some possible exceptions as judged by the trial team).
• People with a history of misusing drugs affecting mental health, or who have a mental health condition that cannot be managed.
• People with other serious health conditions that the trial team considers a significant safety risk or that could prevent completion of the study.
• Women who are pregnant or breastfeeding.

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