Phase 2 Oesophageal 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 with a specific type of stomach cancer (adenocarcinoma) of the stomach, the area where the stomach meets the oesophagus, or the lower oesophagus (a specific subtype called Type I Siewert), at an early-to-intermediate stage (not yet spread), and whose tumour tests strongly positive for a protein called HER2.
• People whose blood test (called a Signatera ctDNA test) shows traces of cancer DNA in the bloodstream after surgery.
• People aged 18 or older at the time of signing the consent form.
• People who received chemotherapy before surgery for at least six weeks.
• People who had surgery that successfully removed all visible cancer with clear edges (no cancer cells left at the surgical margins).
• People who have recovered from surgery, in the opinion of the treating doctor.
• People who have not previously been treated with trastuzumab or any other therapy targeting the HER2 protein.
• People whose post-surgery scans show no sign that the cancer has spread to other parts of the body.
• People with a good general level of physical functioning, as rated on a standard medical scale (ECOG score of 0 or 1, meaning fully active or with only minor limitations).
• People whose heart is pumping at a normal level (at least 50% efficiency), confirmed by a heart scan done within 28 days before starting treatment.
• People whose blood counts, liver function, kidney function, and blood clotting results fall within acceptable ranges on tests done within 14 days before being assigned to treatment (confirm specific values with the trial site).
• Women who are past menopause or who test negative for pregnancy before starting the trial, and who agree to use highly effective contraception during the trial and for 7 months after the last dose of the study drug (if of childbearing potential and sexually active with a male partner who has not had a vasectomy).
• Men who are sexually active with a female partner who could become pregnant, and who agree to use a condom with spermicide from the start of the trial until 4 months after the last dose of the study drug.
• People who are able to understand the study and give their written agreement to participate.

Who may not be able to join:

• People with serious uncontrolled illness, active infection, or mental health or personal circumstances that could make it difficult to follow the study requirements safely.
• People who have had a heart attack within the past 6 months, have significant heart failure, unstable chest pain (angina), important heart rhythm problems, or a stroke within the past 6 months.
• People whose heart electrical activity test (ECG) shows an abnormally prolonged result above specific thresholds (confirm exact values with the trial site).
• People who have a history of, or currently have, a lung condition involving inflammation or scarring of the lung tissue (called interstitial lung disease or pneumonitis), or where this cannot be ruled out from scans done at screening.
• People with certain serious lung conditions, including significant lung clots within the past 3 months, severe asthma, severe chronic obstructive pulmonary disease, restricted lung function, or significant fluid around the lungs.
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) that are known or suspected to affect the lungs.
• People who have had an entire lung removed (complete pneumonectomy).
• People with an uncontrolled infection currently requiring intravenous antibiotics, antiviral, or antifungal treatment.
• People who have had another separate cancer in the past 3 years, with certain exceptions such as fully treated non-melanoma skin cancer or other solid cancers considered fully cured (confirm with trial site).
• People who have fluid build-up around the lungs, abdomen, or heart that requires drainage, or who have a peritoneal shunt.
• People who still have significant side effects from previous cancer treatments that have not returned to a mild or baseline level (with some exceptions at the doctor's discretion).
• People with a known allergy or sensitivity to the study drug (T-DXd/trastuzumab deruxtecan) or any of its components.
• People with a history of severe allergic reactions to other monoclonal antibody treatments.
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People involved in planning or running this study.
• People with substance use issues or other medical conditions that, in the treating doctor's opinion, could interfere with safe participation or accurate assessment of results.
• People who have received a live or attenuated (weakened) vaccine within 30 days before the first dose of the study drug.
• People with a known immune deficiency condition, active HIV infection, or active hepatitis B or C infection (people with a past hepatitis C exposure may be eligible if a specific follow-up blood test is negative — confirm with trial site).
• People who, in the treating doctor's judgement, are unlikely to be able to follow the study's requirements and restrictions.

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