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 chosen to take part voluntarily and are willing to sign a consent form.
• People aged 18 or older at the time of signing the consent form (any gender).
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by a tissue sample to be a type called adenocarcinoma, and who have not yet received any cancer treatment for this condition.
• People who have not had any previous systemic (whole-body) treatment for advanced or spread cancer — though earlier chemotherapy, radiotherapy, or combined chemo-radiotherapy given before or after surgery is allowed, provided the last treatment was at least 6 months before joining; limited palliative radiotherapy is also allowed if it was completed at least 2 weeks before joining.
• People whose cancer has tested negative for a protein called HER2, or whose HER2 status has not yet been tested.
• People who have at least one tumour that can be measured using standard imaging criteria (RECIST v1.1).
• People who are reasonably active and able to carry out everyday activities, as measured by a standard scale called ECOG, with a score of 0 or 1 (confirm with trial site).
• People whose doctors estimate they are likely to survive for more than 12 weeks.
• People whose blood, kidney, liver, and other organ functions meet specific minimum levels set by the trial (the trial site will check these through blood and urine tests).
• People whose thyroid hormone levels are within the normal range, or who have an abnormal thyroid-stimulating hormone level but normal levels of the related hormones T3 and T4.
• Women of childbearing age who have a negative pregnancy test within 3 days before starting the trial medication, and who agree to use highly effective contraception during the trial and for 3 months after the last dose.
• Men with a partner who could become pregnant, who have either had a surgical sterilisation procedure or agree to use effective contraception during the trial and for 3 months after the last dose.

Who may not be able to join:

• People who have previously been treated with certain immune checkpoint drugs, including PD-1, PD-L1, or CTLA-4 inhibitors.
• People who have had a serious allergic reaction to monoclonal antibody medications or to ingredients in similar products.
• People who have used immune-suppressing medications within 14 days before the first dose, with the exception of low-dose steroid sprays, inhalers, or very low daily doses of steroids (up to 10 mg/day of prednisolone or equivalent).
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the trial.
• People whose cancer has spread to the brain or spinal fluid and is not well controlled, or who have a history of cancer spread to the membranes surrounding the brain.
• People who still have significant side effects from previous cancer treatment that have not recovered to a mild level, with some exceptions such as hair loss.
• People whose cancer is at an advanced stage with serious, life-threatening complications in the near term, such as very large uncontrolled fluid build-up in the chest, heart, or abdomen, cancer spreading through the lung's lymph vessels, or more than 30% of the liver affected by cancer.
• People who have an active autoimmune disease, or a history of autoimmune conditions such as autoimmune hepatitis, lung inflammation, eye inflammation, gut inflammation, kidney inflammation, thyroid problems, or blood vessel inflammation (some exceptions, such as vitiligo or childhood asthma that resolved without treatment, may be considered — confirm with trial site).
• People who have been diagnosed with another cancer in the past 3 years, except for certain treated skin cancers or cervical carcinoma in situ.
• People with HIV infection or AIDS, active hepatitis B, active hepatitis C, or a combination of hepatitis B and C infections.
• People who have had a heart attack, severe chest pain, significant heart failure, poorly controlled irregular heartbeat, stroke, mini-stroke, or blood clots in the lungs within 6 months before joining the trial, or who have certain abnormal heart rhythm measurements on an ECG.
• People with high blood pressure that remains above 140/90 mmHg despite taking blood pressure medication.
• People with blood clotting problems, a tendency to bleed, or who are currently receiving blood-thinning or clot-dissolving treatment.
• People with a known inherited or acquired condition affecting bleeding or clotting, such as haemophilia or a disorder of the spleen (confirm with trial site).
• People who have coughed up blood, or have had daily coughing of blood of 2.5 ml or more in the 2 months before joining.
• People who have had significant bleeding symptoms within the 3 months before joining, such as stomach or gut bleeding, bleeding stomach ulcers, or blood vessel inflammation.
• People who have had a blood clot event — such as a stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism — within 6 months before joining.
• People who are on long-term anticoagulant therapy with warfarin or heparin, or long-term high-dose antiplatelet therapy.
• People who have had a serious infection requiring intravenous antibiotics or antifungal/antiviral treatment within 4 weeks before the first dose, or who have an unexplained fever above 38.5°C at the time of screening.
• People who have previously had an organ transplant or bone marrow/stem cell transplant from a donor.
• People who have taken part in another clinical drug trial within 4 weeks before the first dose, or within 5 half-lives of the last trial drug received (whichever is longer — confirm with trial site).
• People with a known history of substance abuse or illicit drug use.
• People with serious physical or mental health conditions, or abnormal test results, that the trial doctors consider would make participation unsafe or could affect the trial results.

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