Phase 2 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:

• People who are 18 years of age or older.
• People who have had surgery to remove stomach cancer, cancer at the junction of the stomach and food pipe (gastroesophageal junction), or adenocarcinoma of the food pipe (esophagus), after completing pre-operative chemotherapy with a regimen called FLOT.
• People whose cancer shows a specific protein called HER2 at high levels, confirmed by testing on the tissue removed during surgery.
• People whose post-surgery blood test (called a liquid biopsy, done 2–6 weeks after surgery) shows signs of remaining cancer DNA in the bloodstream.
• People with no signs of cancer that has spread to distant parts of the body, confirmed by scans after surgery.
• People who are generally well enough to carry out daily activities with little or no restriction (as measured by a standard medical scale called ECOG Performance Status 0–1).
• People with a life expectancy of at least 12 weeks.
• People whose heart is pumping adequately, with a heart function measurement (called LVEF) of 50% or more, checked within 28 days before joining the trial.
• People whose blood counts, liver, kidney, and other organ function results are within acceptable ranges, tested within 14 days before joining the trial (confirm specific values with the trial site).
• People who are able and willing to follow all study procedures and attend all required visits at the participating centre.
• People who provide written agreement (informed consent) to take part before any study procedures begin.
• Women who are past menopause (no period for 12 months without another medical cause) or who have a negative pregnancy blood test at screening, if they are of childbearing potential and sexually active with a male partner who has not been sterilised.
• Women of childbearing potential who agree to use at least one highly effective method of contraception from screening until 7 months after the last dose of study treatment, and who agree not to breastfeed during the study and for 7 months after the last dose.
• Men who are not sterilised and are sexually active with a female partner who could become pregnant, who agree to use a condom with spermicide from screening until 4 months after the last dose of one study drug (T-DXd) or 6 months after the last dose of the other study drugs (docetaxel and oxaliplatin).
• Men who agree not to father a child and to refrain from donating or freezing sperm from the time of joining the trial until 4–6 months after the last dose of study treatment (depending on the drug received).
• Women who agree not to donate or retrieve eggs for personal use from the time of joining the trial until at least 7 months after the last study drug dose.

Who may not be able to join:

• People with signs that cancer has spread to distant parts of the body.
• People who are currently involved in planning or running this study.
• People who have taken part in another clinical trial with an experimental treatment within the last 12 months.
• People with serious uncontrolled illnesses, including active infections, uncontrolled high blood pressure, unstable heart conditions, significant nerve problems, severe ongoing diarrhoea, or substance misuse, that in the opinion of the study doctor could interfere with participation or safety.
• People who have had a heart attack within the 6 months before joining, or who have significant heart failure symptoms (confirm with trial site).
• People with certain abnormal heart rhythm readings on an ECG test at screening (confirm specific values with trial site).
• People who have had lung inflammation (called ILD or pneumonitis) in the past that required steroid treatment, who currently have lung inflammation, or where lung inflammation cannot be ruled out on scans at screening.
• People with serious lung conditions such as a blood clot in the lungs within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), or fluid around the lungs, among others.
• People with autoimmune or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where there is known or suspected involvement of the lungs at the time of screening.
• People who have had a complete removal of one lung (pneumonectomy).
• People with an active infection requiring intravenous antibiotics, antiviral, or antifungal medications.
• People with HIV that is not well controlled under treatment, active hepatitis B, or active hepatitis C infection (some exceptions may apply — confirm with trial site).
• People with a primary immune deficiency condition.
• People who have received a live, weakened (attenuated) vaccine within 30 days before the first dose of the study drug T-DXd (note: mRNA vaccines such as some COVID-19 vaccines are not considered live attenuated vaccines).
• People who still have significant side effects (grade 2 or higher, other than hair loss) from previous cancer treatments that have not settled, unless the trial doctor considers them stable and manageable (confirm with trial site).
• People with a known allergy or sensitivity to any of the study drugs or their ingredients.
• People with a history of severe allergic reactions to other antibody-based treatments (monoclonal antibodies).
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People who have had another cancer diagnosed within the past 3 years, with some exceptions such as certain skin cancers, cancers treated with curative intent, or early-stage cancers that were fully treated (confirm with trial site).
• People with fluid build-up around the lungs, in the abdomen, or around the heart that requires drainage or a procedure to manage it.
• People whose heart pumping function (LVEF) is below 50% within 28 days before joining.
• People who have previously been treated with any anti-HER2 therapy.
• People whose surgical tissue sample does not show HER2 overexpression or amplification (i.e., results are IHC 0, IHC 1+, or IHC 2+ without amplification).
• People whose post-surgery liquid biopsy does not detect cancer DNA in the blood.
• People who were found to have a deficiency in an enzyme called DPD (dihydropyrimidine dehydrogenase) before starting pre-operative FLOT chemotherapy.

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