Phase 3 Stomach Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older, of any gender.
• People who have been confirmed by tissue testing to have a type of cancer called adenocarcinoma that has spread (metastatic), originating from the stomach, the junction between the oesophagus and stomach, or the oesophagus.
• People who have already received two or three rounds of treatment for their metastatic cancer (people who had treatment after surgery and whose cancer spread within 6 months of finishing that treatment are considered to have already had one round of metastatic treatment).
• People whose cancer has previously been treated with — or who could not tolerate — specific chemotherapy drugs including platinum-based drugs (oxaliplatin or cisplatin), fluoropyrimidine, and irinotecan and/or a taxane drug (other targeted or immunotherapy drugs may also have been included in prior treatment).
• People who have cancer that can be measured or detected on scans, as assessed using standard criteria called RECIST 1.1.
• People who are generally well enough to carry out daily activities, as rated 0 or 1 on the WHO performance scale (confirm with trial site).
• People whose blood counts, liver function, kidney function, and other organ function tests meet specific minimum levels set by the trial (confirm with trial site for exact values).
• People whose blood clotting tests are within an acceptable range, or who are already on blood-thinning medication.
• Women who have gone through menopause, or women who are pre-menopausal and have a negative pregnancy test before starting the trial.
• People of childbearing potential who agree to use two reliable forms of contraception (one for themselves and one for their partner) during the trial and for 6 months after the last dose of treatment.
• People who are willing and able to read, understand, and sign a consent form before any trial procedures begin.
• People who have a tumour tissue sample available (from surgery or biopsy) that can be provided to the trial.
• People who are willing to take part in biological sample studies as part of the trial.

Who may not be able to join:

• People currently enrolled in another clinical trial that involves an active treatment (participation in an observation-only study or a survival follow-up study may be acceptable — confirm with trial site).
• People who received their last cancer treatment or palliative radiotherapy less than 2 weeks before the planned trial start date.
• People who have had a bowel blockage within the 28 days before starting the trial.
• People who still have significant side effects (grade 2 or higher) from previous cancer treatments that have not resolved, except for nerve-related side effects.
• People who have had more than 3 prior rounds of treatment for their metastatic cancer.
• People who have had a major surgical procedure within 2 weeks before the planned trial start date (note: a minor exploratory procedure such as keyhole investigation surgery is not considered major — confirm with trial site).
• People who have had cancer spread to the membranes surrounding the brain, or who have brain metastases that are causing symptoms or have not been treated; people whose brain metastases have been treated may be eligible if related neurological symptoms have resolved or stabilised.
• People who have had serious heart problems — such as a heart attack, stroke, unstable chest pain, severe heart failure, or low heart pumping function — within the past 6 months.
• People with severe liver disease (classified as Child-Pugh B or C cirrhosis).
• People with an active stomach or duodenal ulcer.
• People who have had a blood clot (including deep vein thrombosis or pulmonary embolism) in the past 6 months.
• People with serious uncontrolled illnesses, including active infection, uncontrolled high blood pressure, lung disease, or serious ongoing gut conditions causing diarrhoea.
• People with mental health or personal circumstances that would make it difficult to follow the trial requirements, or that would significantly increase health risks or affect the ability to give informed consent.
• People with high levels of protein in their urine, above the thresholds set by the trial (confirm with trial site for exact values).
• People who have tested positive for HIV, active hepatitis B, active hepatitis C, or active tuberculosis.
• People with a known allergy or sensitivity to any of the study drugs or their ingredients, including certain colouring agents (tartrazine/E102, sunset yellow/E110) or lactose monohydrate.
• People who have previously been treated with specific drugs including trifluridine/tipiracil, fruquintinib, regorafenib, or any drug in a class called anti-VEGFR tyrosine kinase inhibitors.
• People who have an active infection requiring antibiotics given through a drip at the time of starting the trial.
• People who have had another cancer in the past 3 years, unless it was a localised skin cancer, a non-invasive cancer (in situ), or another localised tumour that was completely removed.
• People who are taking strong medications known to affect a particular liver enzyme system called CYP450 inducers (confirm with trial site for specific medications).
• People who are pregnant or breastfeeding.
• People with inherited conditions affecting the ability to process certain sugars, including congenital galactosaemia, complete lactase deficiency (lactose intolerance), or glucose-galactose malabsorption syndrome.
• People who have had a clinically significant bleeding episode within the past 2 months.

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