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 been newly diagnosed with stomach cancer or cancer at the junction of the stomach and oesophagus, confirmed by a tissue sample, where surgery may be possible
• People whose tumour tests positive for a protein called CLDN18.2, based on a specific laboratory test (VENTANA 43-14A ≥75%)
• People whose cancer is at a certain stage as shown on a CT scan (specifically T3-4/N0 or T2-4/N+, according to a standard cancer staging system)
• People where a CT scan may suggest cancer has spread to the lining of the abdomen, but this has not been confirmed by a keyhole surgical procedure called a laparoscopy
• People who are able to read, understand, and sign a consent form agreeing to the study requirements
• People aged 19 years or older at the time of joining the study
• People who are generally able to carry out daily activities with little or no limitation (a medical scoring system called ECOG performance status of 0 or 1 would be used to assess this — confirm with trial site)
• People whose doctors expect them to live for more than 12 months
• People who weigh more than 30 kg
• People with no nerve damage, or only very mild nerve damage that does not significantly affect daily life (Grade 1 or below on a standard medical scale)
• People whose blood tests show that their bone marrow, liver, and kidneys are functioning adequately, based on specific laboratory measurements
• Women who are confirmed to be past menopause, or women who are not yet past menopause and have a negative pregnancy test before joining
• People who are willing and able to follow the study schedule, including all visits, treatments, and tests

Who may not be able to join:

• People who received an experimental treatment in another clinical trial within the two weeks before joining this study
• People who are currently taking part in another interventional clinical trial (studies that are purely observational or in a follow-up phase may be acceptable — confirm with trial site)
• People who are currently receiving chemotherapy, immunotherapy, biological therapy, or hormonal therapy for cancer (hormonal therapies unrelated to cancer treatment, such as hormone replacement therapy, may be allowed)
• People who had a major surgical procedure within 28 days before receiving the study drug
• People whose cancer has spread to distant parts of the body, including distant lymph nodes
• People who are unable to swallow or take oral (by mouth) medications
• People who have a blockage at the outlet of the stomach or serious stomach bleeding that is affecting their ability to eat, and these conditions have not been treated
• People who have problems absorbing food through the intestines, including bowel blockage, chronic inflammatory bowel disease, a history of having a large portion of the bowel removed, or a condition called gastric dumping syndrome
• People who have previously had an organ transplant
• People with serious uncontrolled health conditions, including active infections, heart failure with symptoms, uncontrolled high blood pressure, unstable chest pain, irregular heart rhythm, lung disease affecting the air sacs, serious ongoing bowel conditions with diarrhoea, or mental health or social conditions that would prevent safe participation in the study
• People with a history of another cancer, unless they have been free of that cancer for at least 5 years after curative treatment with a low chance of it returning, or they have been successfully treated for certain skin cancers or early-stage cancers confined to one location
• People with a history of a congenital (present from birth) immune system deficiency
• People with active tuberculosis or HIV infection (people with a treated or past tuberculosis infection may be eligible — confirm with trial site; people with hepatitis B may be eligible if receiving appropriate antiviral treatment — confirm with trial site)
• Women who are pregnant or breastfeeding, or people of childbearing potential who are unwilling to use effective contraception from the screening period until 90 days after the last dose of the study drug
• People with a known allergy or hypersensitivity to the study drug or any of its ingredients

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