Phase 3 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 understand the study, are willing to follow its requirements, and are happy to sign a consent form agreeing to take part.
• People aged 18 to 75 years old.
• People who have been diagnosed with advanced stomach cancer or cancer of the junction between the stomach and oesophagus that cannot be surgically removed, or that has spread to other parts of the body — confirmed by a tissue or cell sample.
• People who have not previously received any systemic (whole-body) treatment for this cancer. Note: People who previously received treatment before or after surgery may still be considered, as long as that treatment ended at least 6 months ago and the cancer did not return or worsen during that time.
• People who are able to provide a previously stored tumour tissue sample, or who are willing to have a biopsy taken to collect tumour tissue.
• People whose general health and ability to carry out daily activities meets a specific standard set by doctors (called ECOG performance status 0 or 1 — confirm with trial site).
• People whose doctors estimate they are likely to live for at least 3 more months.
• People whose blood counts, liver function, and kidney function are within acceptable ranges based on blood tests taken within 7 days before joining the trial (confirm specific values with trial site).
• People of childbearing potential, and men whose partners could become pregnant, who are willing to use effective contraception throughout the treatment period and for 6 months afterwards.

Who may not be able to join:

• People who have previously been treated with certain immunotherapy drugs that work on immune checkpoints (such as anti-PD-1, anti-PD-L1, or CTLA-4 antibodies).
• People who have received cancer-fighting drugs, biological therapies, immunotherapy, or any other experimental treatments within the 4 weeks before joining.
• People who have had radiotherapy within the 4 weeks before starting the trial.
• People who have had major surgery within the 4 weeks before joining, or who have not yet fully recovered from a previous surgery.
• People who currently have active, symptomatic cancer spread to the brain or the lining around the brain. People who have had brain metastases that have been treated and have been stable for at least 4 weeks, with neurological symptoms that have largely resolved, may still be considered (confirm with trial site).
• People with a history of another type of cancer, with some exceptions: cancers that have been in complete remission for at least 2 years and need no further treatment; certain treated skin cancers with no sign of return; or treated early-stage cancers confined to one area with no sign of return.
• People who have an active autoimmune disease that required ongoing medical treatment within the past 2 years. Some replacement therapies (such as thyroid hormone or insulin) are permitted (confirm with trial site).
• People who have a known history of a primary immune deficiency condition.
• People who have had a stomach or intestinal perforation or an abnormal tunnel (fistula) form in their digestive system within the past 6 months.
• People who currently have a bowel obstruction, including a partial blockage that requires intravenous nutrition.
• People whose cancer has tested positive for HER2 (a specific protein marker) based on standard laboratory testing.
• People with poorly controlled heart conditions, including: severe heart failure within the past 6 months; unstable chest pain (angina); a heart attack within the past 6 months; or significant heart rhythm problems within the past 6 months that required treatment.
• People who are HIV positive.
• People with active hepatitis B or active hepatitis C, based on specific blood test results (confirm with trial site).
• People with a severe or poorly controlled active infection, including those hospitalised for a serious infection, blood poisoning, or severe pneumonia within the 4 weeks before starting the trial.
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from another person.
• People with a known allergy or intolerance to any of the medicines used in this trial.
• People who have received a live vaccine within the 4 weeks before starting the trial, or who plan to receive one during the study.
• People who still have significant side effects from previous cancer treatment that have not yet resolved to a mild or absent level.

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