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 agreed to take part voluntarily and have signed a consent form
• People aged 18 or older
• People whose general physical functioning is reasonably well-preserved (rated 0–2 on a standard medical scale, meaning they are able to carry out at least some daily activities without full-time assistance) (confirm with trial site)
• People whose cancer has been confirmed by laboratory testing to be a specific type called adenocarcinoma, located in the stomach or where the stomach meets the oesophagus
• People whose cancer has been staged as advanced (Stage III or IV under the AJCC 8th edition system) and cannot be removed by surgery, as determined by a team of specialists reviewing scans and other tests
• People who have not yet received any systemic treatment (such as chemotherapy or immunotherapy) for their advanced cancer — note that some prior treatments given before or after surgery may or may not count as a previous line of therapy depending on timing (confirm with trial site)
• People whose scans show at least one tumour that can be measured according to standard research criteria (RECIST v1.1)
• People whose blood test results meet specific thresholds for red blood cells, white blood cells, platelets, liver function, kidney function, and protein levels — without having received blood transfusions or certain blood-boosting medications in the 14 days beforehand (confirm with trial site)
• People who do not have other serious illnesses expected to shorten their life to under 5 years
• Women of childbearing potential who test negative for pregnancy within 72 hours before starting treatment, and who agree to use effective contraception during treatment and for 90 days after it ends; male participants whose partners could become pregnant must also agree to use effective contraception during treatment and for 90 days after it ends
• People who agree to provide blood and/or tissue samples for research purposes

Who may not be able to join:

• Women who are pregnant or currently breastfeeding
• People whose cancer tests positive for a protein called HER2
• People who still have side effects from previous cancer treatments (other than hair loss) that have not improved to a mild level (Grade 1 or lower)
• People who have had another type of cancer in the past 5 years, or currently have another cancer — with exceptions for certain fully treated skin cancers or early-stage cervical conditions
• People with a history of uncontrolled epilepsy, brain or nervous system conditions, or mental health disorders that might affect their ability to consent or to take oral medications as required
• People with significant heart problems that are not well controlled, including symptoms of coronary heart disease, moderate-to-severe heart failure, serious irregular heartbeat, a heart attack in the past 12 months, abnormal heart electrical readings (QTc interval above certain thresholds), or reduced heart pumping function
• People who have had a blood clot event — such as a stroke, mini-stroke, brain bleed, deep vein thrombosis, or pulmonary embolism — within the past 6 months
• People who have had significant bleeding symptoms or a clear tendency to bleed within the past 3 months, such as gastrointestinal bleeding or a bleeding stomach ulcer (some exceptions may apply — confirm with trial site)
• People known to have inherited or acquired disorders affecting blood clotting or bleeding, such as haemophilia
• People who have problems absorbing oral medications due to upper digestive tract blockage or malabsorption, or who have had a bowel perforation, abdominal abscess, or bowel obstruction in the past 3 months
• People with abnormal blood clotting results, or who are currently receiving clot-dissolving or anticoagulant medications (low-dose aspirin or low-molecular-weight heparin for prevention may be acceptable — confirm with trial site)
• People with nerve damage from prior chemotherapy that would make them unsuitable for a specific drug called oxaliplatin — relevant to one treatment group in this trial (confirm with trial site)
• People who have had an organ transplant and require anti-rejection medications, or who have taken immunosuppressive drugs or high-dose steroids within 14 days before starting the trial
• People with active ulcers, wounds that have not healed, or fractures
• People with high blood pressure that remains uncontrolled despite medication (systolic at or above 140 mmHg or diastolic at or above 90 mmHg)
• People with known allergies to any of the study drugs or their ingredients, or who have significant protein in their urine on testing
• People with fluid build-up in body cavities (such as the abdomen, lungs, or around the heart) that is causing symptoms and requires active management — though people with no symptoms, or whose symptoms are well-controlled after drainage, may be considered (confirm with trial site)
• People with active hepatitis B or C infection meeting specific viral load thresholds, or people currently needing antibiotic or antifungal treatment for an active infection
• People with current or prior lung conditions such as pulmonary fibrosis, organising pneumonia, drug-related lung inflammation, or active pneumonia, or those with significantly reduced lung function on screening
• People with active autoimmune diseases or a history of autoimmune conditions that could flare up — some exceptions may apply for certain manageable conditions such as thyroid disorders on hormone replacement, type 1 diabetes controlled with insulin, or mild skin conditions not requiring systemic treatment (confirm with trial site); people with asthma requiring reliever medication are not eligible

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