Phase 3 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 diagnosed with a specific type of stomach or stomach-oesophagus junction cancer (called adenocarcinoma, diffuse or mixed type) that has tested negative for a protein called HER-2.
• People whose cancer has not yet been treated and is locally advanced (meaning it has grown into the stomach wall and/or nearby lymph nodes, but has not spread to distant parts of the body).
• People with a tumour located at a particular part of the stomach-oesophagus junction (called Siewert type 2 or 3); people with Siewert type 1 tumours may also be considered if their planned treatment includes chemotherapy before surgery followed by surgical removal (confirm with trial site).
• People aged between 18 and 75 years at the time of signing the consent form.
• People whose expected survival is at least 12 weeks.
• People who are generally well enough to carry out daily activities with little or no limitation, as rated by a standard medical scale called ECOG 0 or 1 (confirm with trial site).
• Men who are sexually active with a female partner who could become pregnant must use effective contraception from the start of treatment until 120 days after the last dose.
• Women who could become pregnant must use highly effective contraception throughout the study and for 120 days after the last dose — methods such as hormonal contraception combined with a barrier method are required; periodic abstinence and withdrawal methods are not acceptable.
• People whose blood counts, liver, kidney, and clotting function meet specific healthy ranges as measured by blood tests (confirm exact values with trial site).
• People who have had no heart attack in the past six months, and whose blood pressure and any existing heart conditions are well controlled.
• People who are willing and able to sign a written consent form agreeing to take part.
• People who have not previously received any cancer treatment, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
• People who are planned to have surgery after pre-operative chemotherapy.
• People who are willing to provide tumour tissue and blood samples at the start of the study and again at the time of surgery.

Who may not be able to join:

• People who have a history of lung inflammation (pneumonitis) that required steroid treatment, or who currently have pneumonitis.
• People who have another cancer that is currently active or has required treatment within the past 5 years (certain skin cancers or non-spreading cancers that have been successfully treated may be exceptions — confirm with trial site).
• People who have an active infection that requires treatment with medicines given throughout the whole body.
• People who have an active autoimmune disease (where the immune system attacks the body) that has needed whole-body treatment within the past 2 years (some milder autoimmune conditions may be exceptions — confirm with trial site).
• People who have needed corticosteroid medicines (such as prednisone at doses above 10mg per day) or other immune-suppressing medicines in the 14 days before starting the trial (routine hormone replacement therapy is generally allowed).
• People with a known history of a primary immune deficiency condition.
• People who have received a live vaccine or certain immune-boosting treatments within 30 days before the first dose of trial treatment.
• People with a known history of active tuberculosis.
• People who have had an organ transplant or bone marrow/stem cell transplant from another person.
• People who are known to be severely allergic to any of the study drugs or their ingredients.
• People with significant heart or blood vessel problems, including serious heart rhythm disorders, poor heart pumping function, or a history of stroke or blood clots (confirm specific details with trial site).
• People who are currently enrolled in another clinical trial that involves an active treatment (observational studies or follow-up-only phases may be acceptable — confirm with trial site).
• People who have previously received certain immunotherapy treatments that target specific immune pathways (such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapies).
• People whose tumour tests positive for the HER-2 protein.
• People who are unable or unwilling to provide tumour tissue and blood samples.
• People who are pregnant, breastfeeding, or planning to become pregnant within 5 months after the study ends; women who could become pregnant are required to have a blood pregnancy test within 7 days before starting the study.

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