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 are willing to take part voluntarily and have signed the consent form after being fully informed about the study.
• You are between 18 and 80 years old (any gender).
• You have been confirmed by a tissue test (biopsy) to have stomach cancer or cancer at the junction of the esophagus and stomach (a specific type called adenocarcinoma).
• Your cancer tests show a high level of a protein called HER2, confirmed through specific laboratory tests on your biopsy tissue.
• Your cancer has been staged as locally advanced (not yet spread to distant parts of the body), based on standard staging guidelines.
• You are in good enough general health to carry out daily activities, as measured by a standard doctor's assessment done within 7 days before starting treatment.
• Your doctors expect you to live for at least 6 months.
• You agree to provide tissue samples from your biopsy and surgery, as well as blood, stool, and urine samples for research testing.
• Your blood test results show that your blood counts, liver, kidneys, blood clotting, and heart function are all within acceptable ranges (as measured within 14 days before starting treatment).
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 7 days before starting treatment, not be breastfeeding, and agree to use reliable contraception or abstain from sex for a set period after treatment ends.
• If you are a man, you must agree to use reliable contraception or abstain from sex for a set period after treatment ends.

Who may not be able to join:

• You have previously received any treatment for stomach cancer, including surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
• You have had or currently have another active cancer in the past 5 years (some very early or treated skin and reproductive cancers may be exceptions — confirm with trial site).
• You have a blockage in your stomach outlet, are unable to swallow/eat by mouth, or have serious bleeding in your digestive system.
• You have had a heart attack in the last 6 months, have uncontrolled chest pain, a heart rhythm problem requiring treatment (such as a pacemaker), or have moderate-to-severe heart failure.
• You have ongoing chronic diarrhea (watery, 5 or more times per day).
• You have an active infection requiring medical treatment within 14 days before starting the trial.
• You have active tuberculosis (TB).
• You have been diagnosed with, or have symptoms of, a lung condition called interstitial lung disease.
• You test positive for HIV, hepatitis B, or hepatitis C.
• You need long-term use of steroid medications (above a certain dose) or other medicines that suppress the immune system, within 14 days before starting or during the trial.
• You have had a severe allergic reaction to any antibody-based medication in the past or currently.
• You have an active autoimmune disease (some conditions like type 1 diabetes or an underactive thyroid managed only with hormone replacement may be exceptions — confirm with trial site).
• You have received a live vaccine within 28 days before starting the trial or during the trial (standard inactivated flu vaccines are generally allowed — confirm with trial site).
• You have a history of receiving a donated organ transplant or donated stem cell transplant.
• You have a serious ongoing illness (such as uncontrolled diabetes or high blood pressure) that has not responded well to treatment.
• Your doctor judges that you have other serious physical or mental health conditions, or abnormal test results, that make participation unsafe or unsuitable.

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