Phase 1 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 signed a written consent form agreeing to take part in the study.
• People who are 18 years of age or older at the time they sign the consent form.
• People who have been diagnosed through a tissue biopsy with a certain type of stomach, oesophageal, or junction (where the oesophagus meets the stomach) cancer that has grown locally but has not spread to distant parts of the body, is considered removable by surgery, and does not involve distant areas of the abdominal lining (confirm with trial site for specific staging details).
• People whose tumour tissue is available for testing at the trial site to check for specific markers related to immune response.
• People who are generally well enough to carry out light daily activities, with little or no limitation (known medically as ECOG performance status 0 or 1 — confirm with trial site).
• People whose blood counts, liver function, and kidney function meet specific minimum levels as determined by blood tests (confirm with trial site for exact values).
• Women who could become pregnant must agree to use highly effective contraception or remain abstinent during treatment and for at least 4 months after the last dose of the immunotherapy drug or 6 months after the last dose of chemotherapy, whichever is later.
• Male participants with female partners who could become pregnant must agree to use barrier contraception or remain abstinent during the same period, and must not donate sperm during this time.

Who may not be able to join:

• People who have previously received chemotherapy, radiotherapy, or immunotherapy for this cancer, or who have received treatment for any other cancer within the past five years.
• People who have previously had part or all of their oesophagus or stomach surgically removed.
• People who have a known allergy or serious sensitivity to any ingredient in the study drug tislelizumab, or to similar types of biological medicines used in treatment.
• People who have a history of non-infectious lung inflammation (pneumonitis) or scarring of the lung tissue (interstitial lung disease) that required steroid treatment, or who currently have these conditions.
• People who have significant ongoing lung conditions, such as a blood clot in the lungs within the past three months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restricted lung function, or fluid around the lungs.
• People whose heart pumping function is below a certain level as measured by an ultrasound of the heart (echocardiogram showing the heart pumping less than 50% efficiency).
• People who are known to have a complete absence of an enzyme called DPD (dihydropyrimidine dehydrogenase), which is needed to process certain chemotherapy drugs safely.
• People who have taken certain antiviral medicines (brivudine, sorivudine, or similar drugs) within 28 days before joining the study.
• People who have a specific type of anaemia caused by vitamin B12 deficiency (pernicious anaemia or megaloblastic anaemia).
• People who have nerve damage in their hands or feet that affects their ability to function normally.
• People who have had a heart attack within the past 6 months, or who have moderate to severe heart failure with noticeable symptoms.
• People whose heart's electrical activity shows a prolonged interval on an ECG recording beyond specific limits (greater than 470 milliseconds for women or 450 milliseconds for men — confirm with trial site).
• People who have another cancer that is currently active or has required treatment within the past 2 years (some skin cancers or cancers that have been fully treated with curative intent may still be eligible — confirm with trial site).
• People who have an active serious infection that requires intravenous (IV) antibiotics, antiviral, or antifungal treatment.
• People who have a primary immune system disorder, uncontrolled HIV infection, or active hepatitis B or C infection (some people with a past resolved hepatitis B infection may still be eligible under specific conditions — confirm with trial site).
• People who have an active autoimmune disease or a history of autoimmune conditions, such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, or similar conditions.
• People who have received immune-stimulating treatments (such as interferons or interleukin-2) within four weeks or five half-lives of the drug before joining the study, whichever period is longer.
• People who have taken steroid tablets or other immune-suppressing medicines within the 2 weeks before joining the study (inhaled steroids or certain other steroid forms are generally still permitted — confirm with trial site).
• People who have previously had a bone marrow transplant from a donor or a solid organ transplant (such as a kidney or liver transplant).
• People who have received a live vaccine within 30 days before starting the study treatment.
• People who have another serious medical condition that, in the treating doctor's judgement, would create a high risk of complications or make the treatment unlikely to be effective.
• People who are currently taking part in another clinical drug trial, or who have done so within the past 28 days (participation in observational studies without an intervention may be acceptable — confirm with trial site).
• People who have taken an experimental or investigational drug within 28 days before starting the study.
• Women who are currently pregnant, breastfeeding, or planning to become pregnant within 7 months of the last dose of study treatment; women of childbearing potential must have a negative blood pregnancy test within 7 days before starting treatment.

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