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 aged 18 to 75 years old, of any gender.
• People with a good general health and activity level, rated 0 or 1 on a standard performance scale used by doctors (called ECOG score).
• People who have been diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus that cannot be surgically removed, or that has spread to other parts of the body, confirmed by a tissue biopsy.
• People who have already received at least one round of immunotherapy treatment that either stopped working or caused intolerable side effects, and who have had no more than two prior rounds of systemic (whole-body) treatment in total; the best response to the prior immunotherapy must have been complete response, partial response, or stable disease.
• People who have at least one measurable area of cancer that has not been treated with radiation therapy (or, if it was previously treated with radiation, where progression of the cancer has since been confirmed).
• People whose blood and organ function meet specific levels, including: sufficient white blood cells, platelets, and haemoglobin without recent support treatments; liver and kidney function within acceptable ranges; normal blood clotting levels; and heart enzyme levels within normal range.
• People who are expected to live for at least 3 months.
• Women of childbearing potential who agree to use effective contraception during the study and for 6 months after it ends, have a negative pregnancy test within 7 days before joining, and are not breastfeeding.
• Men who agree to use contraception during the study and for 6 months after it ends.
• People who are willing and able to sign a consent form agreeing to take part.

Who may not be able to join:

• People who have previously received paclitaxel (a type of chemotherapy); however, people who received a similar drug (taxoid) as pre- or post-surgery treatment and whose disease did not return or worsen until more than 6 months after finishing that chemotherapy may still be considered.
• People whose cancer tests positive for a marker called HER2.
• People currently taking immune-suppressing medications or hormone therapy at doses above a certain level (more than 10mg per day of prednisone or equivalent) within 2 weeks before joining.
• People with severely reduced liver, kidney, or heart function.
• People who have difficulty taking oral (swallowed) medication, for example due to difficulty swallowing, prior removal of part of the digestive system, persistent diarrhoea, or a bowel blockage.
• People who have cancer that has spread to the brain and is causing symptoms, or where symptoms have only been controlled for less than 3 months.
• People known to be allergic to any of the study drugs or their ingredients.
• People who are pregnant or currently breastfeeding.
• People who had major surgery (such as brain, chest, or abdominal surgery) within 4 weeks before the first dose, or who have wounds, ulcers, or fractures that have not healed; exceptions may apply in certain circumstances (confirm with trial site).
• People with moderate to severe fluid build-up in the abdomen causing symptoms that require repeated drainage, or uncontrolled fluid around the lungs or heart.
• People with significantly abnormal levels of electrolytes (salts and minerals) in the blood that are causing clinical concern.
• People with active hepatitis B or hepatitis C infection above certain virus levels, or who test positive for hepatitis B surface antigen or hepatitis C antibodies.
• People with cancer spread to the brain that is currently causing symptoms, unless it has been treated, is stable, and has been controlled for at least 4 weeks, with measurable disease elsewhere in the body and steroid treatment stopped at least 14 days before starting the study.
• People who have had a serious, life-threatening bleeding event in the past 3 months, including those who needed a blood transfusion, surgery, or ongoing medication for it.
• People who have had a blood clot or blockage in an artery or vein in the past 6 months, such as a heart attack, stroke, pulmonary embolism, or deep vein thrombosis; certain stable or minor clot-related conditions may be exceptions (confirm with trial site).
• People with high blood pressure that remains above certain levels despite treatment, or who have a history of a hypertensive crisis or hypertensive brain condition.
• People with significant heart failure causing symptoms, poorly controlled irregular heartbeat, a history of a specific inherited heart rhythm condition, or an abnormal heart rhythm reading above a certain level on an ECG.
• People who received radiation therapy within 4 weeks before the first dose, or whose radiation-related side effects have not fully resolved (confirm with trial site for specific conditions that must be met).
• People with existing lung conditions such as pulmonary fibrosis, interstitial lung disease, dust-related lung disease, drug-related lung inflammation, or severely reduced lung function.
• People who are HIV positive or have a known syphilis infection.
• People with unhealed wounds, bone fractures, stomach or intestinal ulcers, persistent blood in the stool, ulcerative colitis, or other conditions that a doctor determines may cause gastrointestinal bleeding or perforation.
• People who still have side effects from previous treatments that have not returned to near-normal levels (with the exception of hair loss or mild nerve-related symptoms in the hands or feet).
• People with serious active infections, or who were hospitalised for a severe infection, blood infection, or severe pneumonia within the 4 weeks before the first dose.
• People who have taken immune-suppressing medications within 4 weeks before the first dose, with certain exceptions such as low-dose steroids or inhaled/topical steroids.
• People who received a live vaccine within 4 weeks before joining, or who plan to receive one during the study.
• People who had major surgery or a significant injury within 4 weeks before the first dose.
• People who received traditional Chinese herbal medicine with anti-cancer indications within 2 weeks before the first dose.
• People who have had a gastrointestinal perforation or abscess within 6 months before joining.
• People who have taken part in another clinical trial within 4 weeks before the first dose.
• People whose urine tests show a significant level of protein (2+ or higher on a urine test, or more than 1.0g of protein in a 24-hour urine collection).
• People with an active autoimmune disease or a history of certain autoimmune conditions (such as autoimmune hepatitis, inflammatory lung or bowel disease, or inflammation of blood vessels or kidneys); some conditions such as well-controlled type 1 diabetes, treated thyroid conditions, vitiligo, psoriasis, or hair loss may still be acceptable (confirm with trial site).
• People with other serious medical or psychiatric conditions, or significant laboratory abnormalities, that a doctor determines would make participation unsafe or affect the study results.
• People considered unsuitable for any other reason by the treating doctor or research team.

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