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:

• You have read and fully understood the study information and have freely agreed to take part by signing a consent form
• You are between 18 and 75 years old (inclusive)
• You have been diagnosed through a biopsy or tissue test with advanced stomach cancer or cancer at the junction of the stomach and food pipe (a specific type called adenocarcinoma)
• You have not previously received any anti-cancer treatment for your cancer that has spread to other parts of the body
• Your cancer tests positive for a protein called HER2
• You are generally able to carry out daily activities with little or no limitation (a doctor will assess this using a standard scale rated 0–1)
• Your doctors expect you to live for at least 3 months
• You have at least one area of cancer that can be measured on a scan
• Your blood counts and organ function (including your liver, kidneys, and blood cells) meet certain minimum levels — you must not have received blood products or growth factor injections in the 14 days before joining
• If you are a woman who could become pregnant, you are using effective contraception
• You are willing and able to attend follow-up appointments and follow the study plan

Who may not be able to join:

• You are unable or unwilling to follow the study rules and procedures
• You have previously been treated with certain targeted drugs (VEGFR inhibitors), chemotherapy, or immunotherapy
• You have had another type of cancer in the past 5 years — exceptions may apply for certain treated skin cancers or early-stage cervical changes (confirm with trial site)
• You have cancer that has spread to the brain or spinal fluid and is causing symptoms
• You have an autoimmune disease (where your immune system attacks your own body) or have had one in the past 4 weeks
• You have previously had a bone marrow transplant or an organ transplant from another person
• You have a build-up of fluid in your abdomen that cannot be controlled with medication or drainage procedures
• You have had serious heart problems such as unstable chest pain or a heart attack in the past 6 months
• You are known to be allergic to the study drug or any of its ingredients
• You have taken part in another clinical trial using an unapproved drug in the past 4 weeks
• Your blood clotting test results are above a certain level, suggesting a higher risk of bleeding (confirm with trial site)
• You have significant abnormalities in your blood salt (electrolyte) levels, as judged by the doctor
• You have high blood pressure that cannot be controlled with medication (specifically, top number 140 or higher and/or bottom number 90 or higher)
• You have poorly controlled diabetes, even after treatment
• You have a condition that affects how you absorb medication, or you are unable to swallow tablets
• You have active stomach or intestinal problems such as stomach ulcers, bowel inflammation, or a risk of bleeding or a hole forming in the gut
• You have had significant bleeding in the past 3 months, coughed up blood recently, or had a blood clot, stroke, or mini-stroke in the past 12 months
• You have significant heart problems, including recent heart attack, severe chest pain, heart bypass surgery, heart failure above a certain level, irregular heart rhythm needing treatment, or your heart pumping function is below (or above) a certain threshold (confirm with trial site)
• You still have side effects from previous cancer treatment that have not fully resolved (with some exceptions such as hair loss)
• You are pregnant or breastfeeding
• You have received a blood transfusion, blood products, or certain growth factor injections within the past 14 days
• You have protein showing up in your urine above a certain level
• You need long-term use of drugs that suppress the immune system, or steroid medications above a low daily dose
• You have any other medical condition that the doctor believes makes it unsafe or unsuitable for you to take part
• The study doctor has any other concern that makes you unsuitable for the trial

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