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 diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus (excluding a specific type called Siewert type I), confirmed by a tissue sample test.
• People whose cancer has spread (metastasised) only in a limited way — either to lymph nodes behind the abdomen, or to at most one other organ, with no sign of cancer spreading across the lining of the abdomen (confirmed by a keyhole inspection procedure).
• People who have at least one measurable area of cancer visible on a CT or MRI scan.
• People whose cancer has been tested and the HER2 status is known.
• People whose cancer has been tested and shown to have normal DNA repair function (called pMMR or MSS), confirmed by laboratory tests.
• People aged 18 to 75 years, male or female.
• People who are generally well enough to carry out daily activities with little or no limitation (based on a standard medical fitness score of 0 or 1).
• People whose overall health and organ function are suitable to receive the planned treatments in this trial, which may include chemotherapy, immunotherapy, radiotherapy, and surgery.
• People who have not previously had surgery or any cancer treatment such as chemotherapy, radiotherapy, or immunotherapy for this cancer.
• People whose blood count results meet specific minimum levels — including white blood cells, platelets, and haemoglobin (confirm with trial site for exact values).
• People whose liver function blood test results are within the ranges required by the trial.
• People whose kidney function results meet the required levels.
• People whose blood clotting test results are within the required ranges.
• People whose thyroid hormone levels are within normal ranges, or whose detailed thyroid results are acceptable to the trial team (confirm with trial site).
• People whose urine protein levels are within acceptable limits as tested at the start of the trial.
• People who do not have any serious other illnesses, and whose life expectancy is more than 6 months.
• People who are willing and able to follow the trial schedule, including attending treatments and follow-up appointments.
• People who agree to provide blood and tissue samples for research.
• Female patients who are not pregnant or breastfeeding, and who agree to use contraception during treatment and for a set period after the last dose.

Who may not be able to join:

• People who have already had surgery, chemotherapy, radiotherapy, or immunotherapy for their stomach cancer.
• People who have had another cancer in the past 5 years, except for certain skin cancers or early-stage cancers that were fully treated (such as cervical carcinoma in situ, breast cancer in situ, or superficial bladder cancer).
• Females who are pregnant, breastfeeding, planning to become pregnant, or who have a positive pregnancy test at the start of the trial. Women who have not had a period for at least 12 months are considered post-menopausal (confirm with trial site).
• People who are sexually active with a chance of pregnancy and are unwilling to use contraception during the trial.
• People who have had an allergic reaction to any of the drugs that may be used in this trial.
• People who have had a bone marrow or organ transplant from another person.
• People who received a live vaccine within 28 days before joining the trial.
• People who received certain immune-boosting therapies or experimental treatments within 28 days before joining.
• People who have previously been treated with a type of immunotherapy that targets specific immune checkpoint pathways (such as anti-PD-1, PD-L1, or PD-L2 therapies).
• People who have used steroid medicines above a certain dose, or other medicines that suppress the immune system, within 14 days before joining — with some exceptions for short-term or low-absorption steroid use (confirm with trial site).
• People who have lost more than 20% of their body weight in the 2 months before joining.
• People with uncontrolled ongoing illnesses such as diabetes or high blood pressure.
• People who have had uncontrolled fluid build-up around the lungs, heart, or abdomen in the 2 weeks before joining.
• People with serious failure of a major organ such as the heart, lungs, liver, or kidneys.
• People whose kidney function falls below the required level for this trial.
• People who have a specific enzyme deficiency called DPD deficiency, which affects how certain chemotherapy drugs are processed.
• People with conditions affecting the brain or nervous system, including brain metastases or psychiatric illness.
• People who have had a stroke or similar brain blood vessel event within 6 months before joining.
• People who have nerve damage in their hands or feet (peripheral neuropathy), except in certain mild cases (confirm with trial site).
• People with a history of serious heart conditions such as uncontrolled chest pain, irregular heartbeat, heart failure, or heart attack within 6 months before joining.
• People who have had a blood clot in the lungs within 28 days before joining.
• People with a history of certain lung diseases, including lung scarring or non-infectious lung inflammation.
• People who have had gastrointestinal bleeding or are considered at high risk of bleeding in the 2 weeks before joining.
• People who have had a hole or abnormal opening in the gastrointestinal tract within 6 months before joining.
• People who have a blockage or absorption problem in the upper digestive tract that could affect how oral chemotherapy is taken up by the body.
• People who are unable to swallow or take medicine by mouth.
• People with a history of active or hard-to-treat autoimmune disease.
• People with serious ongoing infections requiring treatment with antibiotics, antifungal, or antiviral medicines, including tuberculosis or AIDS.
• People with a known HIV infection.
• People with untreated hepatitis B, high hepatitis B virus levels in the blood, or active hepatitis C infection.
• People with alcohol or drug misuse issues, or medical, psychological, or social circumstances that could interfere with participation or the accuracy of trial results.

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