Phase 3 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 been diagnosed within the last 6 months with a type of slow-growing tumour called a gastroenteropancreatic neuroendocrine tumour (GEP-NET) that has spread to other parts of the body or cannot be surgically removed with the aim of a cure, and which has been confirmed by a tissue sample as Grade 1 or Grade 2 (a low growth rate measured by a specific lab marker called Ki-67 being less than 10%).
• People whose doctor considers them to have a high level of disease burden, guided by factors such as: a tumour or spread larger than 4 cm; more than one tumour or spread larger than 2 cm; certain elevated blood test results; cancer that has spread to the bones or the lining of the abdomen; symptoms caused by tumour size such as pain, tiredness, weight loss, or loss of appetite; or symptoms caused by excess hormones needing active management — or other disease features that the doctor considers significant.
• People aged 12 years or older.
• People whose tumours show sufficient uptake on a specialised nuclear medicine scan (called a somatostatin receptor imaging scan) performed within the last 3 months, at a level at least equal to normal liver uptake.
• People with blood test results showing adequate bone marrow and organ function before starting treatment, including sufficient white blood cells, platelets, haemoglobin, kidney function, and liver function, with potassium levels within acceptable ranges.
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or restricted in strenuous activity but able to carry out light work).
• People who have at least one tumour site that can be measured on scans.

Who may not be able to join:

• People who have previously received any radioactive drug treatment (therapeutic radiopharmaceutical) for GEP-NET at any time before joining the study.
• People who have previously received treatments such as interferons, mTOR-inhibitors, chemotherapy, or other systemic therapies for GEP-NET — other than a class of medication called somatostatin analogues (SSAs).
• People who have received more than 4 cycles of SSA treatment (such as long-acting octreotide), or those whose SSA treatment cannot be paused for the required period before receiving the study drug.
• People whose GEP-NET was confirmed to have grown or worsened during previous SSA treatment, based on standard scan measurement criteria.
• People who have previously had certain procedures targeting liver tumours, including radioembolization, chemoembolization, or radiofrequency ablation for GEP-NET.
• People who have had major surgery within the 12 weeks before joining the study.
• People known to have cancer that has spread to the brain.
• People who are unable to have CT scans with an injected contrast dye due to allergic reactions or kidney problems — unless MRI scanning is a suitable alternative.
• People with a known allergy or sensitivity to somatostatin analogues or to any ingredients in the study medications.
• People with severe urinary incontinence, serious difficulty passing urine, or urinary blockage requiring a permanent catheter, where the doctor believes this could prevent the person from safely following radiation safety instructions.
• Other criteria defined in the study protocol may also apply (confirm with trial site).

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